Trial Outcomes & Findings for A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema (NCT NCT05151731)
NCT ID: NCT05151731
Last Updated: 2026-05-11
Results Overview
The BCVA, at a starting test distance of 4 meters (m), was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified early treatment diabetic retinopathy study \[ETDRS\] charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a Mixed Model for Repeated Measurements (MMRM) model. Adjusted mean has been reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
394 participants
Primary outcome timeframe
Baseline, Weeks 44 and 48
Results posted on
2026-05-11
Participant Flow
A total of 394 participants with diabetic macular edema (DME) took part in the study at 74 investigative sites across Argentina, Canada, Czech Republic, Spain, Republic of Korea, Poland, the United Kingdom and the United States from 31 December 2021 to 21 April 2025.
Participants were randomized into 1:1:1:1 ratio to 4-parallel arms- 0.25 milligrams (mg) Vamikibart every 8th week (Q8W), 1 mg Vamikibart Q8W, 1 mg Vamikibart every 4th week (Q4W), and 0.5 mg Ranibizumab Q4W, to receive treatment up to Week 44, followed by off-treatment observation.
Participant milestones
| Measure |
Arm A: Vamikibart 0.25 mg Q8W
Participants received vamikibart, 0.25 mg, intravitreal (IVT) injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm C: Vamikibart 1 mg Q4W
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
95
|
101
|
98
|
100
|
|
Overall Study
Safety-evaluable Population
|
94
|
100
|
98
|
98
|
|
Overall Study
Treatment-naïve Intent-to-treat (ITT) Population
|
65
|
65
|
64
|
65
|
|
Overall Study
Previously Treated ITT Population
|
30
|
36
|
34
|
35
|
|
Overall Study
COMPLETED
|
57
|
64
|
64
|
84
|
|
Overall Study
NOT COMPLETED
|
38
|
37
|
34
|
16
|
Reasons for withdrawal
| Measure |
Arm A: Vamikibart 0.25 mg Q8W
Participants received vamikibart, 0.25 mg, intravitreal (IVT) injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm C: Vamikibart 1 mg Q4W
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
9
|
9
|
3
|
|
Overall Study
Death
|
1
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
4
|
3
|
|
Overall Study
Need for Rescue Treatment
|
11
|
10
|
1
|
0
|
|
Overall Study
Non-compliance With Study Drug
|
0
|
0
|
1
|
1
|
|
Overall Study
Reason Not Specified
|
6
|
11
|
6
|
2
|
|
Overall Study
Physician Decision
|
1
|
2
|
4
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
6
|
6
|
Baseline Characteristics
A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Arm D: Ranibizumab 0.5 mg Q4W
n=100 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Total
n=394 Participants
Total of all reporting groups
|
Arm B: Vamikibart 1 mg Q8W
n=101 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=95 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm C: Vamikibart 1 mg Q4W
n=98 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 9.8 • n=1054 Participants
|
62.5 years
STANDARD_DEVIATION 9.7 • n=97 Participants
|
63.2 years
STANDARD_DEVIATION 10.0 • n=10 Participants
|
64.2 years
STANDARD_DEVIATION 9.8 • n=44 Participants
|
62.8 years
STANDARD_DEVIATION 8.7 • n=30 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=1054 Participants
|
184 Participants
n=97 Participants
|
45 Participants
n=10 Participants
|
51 Participants
n=44 Participants
|
43 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=1054 Participants
|
210 Participants
n=97 Participants
|
56 Participants
n=10 Participants
|
44 Participants
n=44 Participants
|
55 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=1054 Participants
|
47 Participants
n=97 Participants
|
14 Participants
n=10 Participants
|
15 Participants
n=44 Participants
|
10 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=1054 Participants
|
198 Participants
n=97 Participants
|
47 Participants
n=10 Participants
|
42 Participants
n=44 Participants
|
54 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
37 Participants
n=1054 Participants
|
149 Participants
n=97 Participants
|
40 Participants
n=10 Participants
|
38 Participants
n=44 Participants
|
34 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1054 Participants
|
4 Participants
n=97 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=44 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=1054 Participants
|
22 Participants
n=97 Participants
|
6 Participants
n=10 Participants
|
5 Participants
n=44 Participants
|
5 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=1054 Participants
|
28 Participants
n=97 Participants
|
6 Participants
n=10 Participants
|
10 Participants
n=44 Participants
|
6 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=1054 Participants
|
180 Participants
n=97 Participants
|
45 Participants
n=10 Participants
|
36 Participants
n=44 Participants
|
49 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
38 Participants
n=1054 Participants
|
160 Participants
n=97 Participants
|
43 Participants
n=10 Participants
|
42 Participants
n=44 Participants
|
37 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 44 and 48Population: Treatment-naïve ITT population included all randomized participants who were naïve to IVT anti-vascular endothelial growth factor (VEGF) or periocular/IVT corticosteroids treatment. Participants were grouped according to the treatment assigned at randomization.
The BCVA, at a starting test distance of 4 meters (m), was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified early treatment diabetic retinopathy study \[ETDRS\] charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a Mixed Model for Repeated Measurements (MMRM) model. Adjusted mean has been reported.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=64 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=65 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=65 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=65 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Change From Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants
|
5.5 ETDRS letters
Standard Error 1.29
|
13.0 ETDRS letters
Standard Error 1.26
|
7.1 ETDRS letters
Standard Error 1.28
|
4.6 ETDRS letters
Standard Error 1.26
|
SECONDARY outcome
Timeframe: Up to Week 72Population: Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received.
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs include all non-ocular AEs. Only one eye was selected as the study eye, while the other was referred to as the fellow eye.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=98 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=98 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=94 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=100 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Number of Participants With Systemic and Ocular Adverse Events (AEs)
Systemic AEs
|
54 Participants
|
65 Participants
|
43 Participants
|
58 Participants
|
|
Number of Participants With Systemic and Ocular Adverse Events (AEs)
Ocular AEs in Study Eye
|
41 Participants
|
31 Participants
|
39 Participants
|
46 Participants
|
|
Number of Participants With Systemic and Ocular Adverse Events (AEs)
Ocular AEs in Fellow Eye
|
24 Participants
|
29 Participants
|
13 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 44 and 48Population: Previously treated ITT population included all randomized participants who were previously treated with IVT anti-VEGF or periocular/IVT corticosteroids treatment. Participants were grouped according to the treatment assigned at randomization.
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=34 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=35 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=30 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=36 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants
|
-0.4 ETDRS letters
Standard Error 2.49
|
9.6 ETDRS letters
Standard Error 2.21
|
2.0 ETDRS letters
Standard Error 2.74
|
-0.5 ETDRS letters
Standard Error 2.39
|
SECONDARY outcome
Timeframe: Baseline, Weeks 44 and 48Population: Overall ITT population included all randomized participants.
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=98 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=100 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=95 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=101 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population
|
3.8 ETDRS letters
Standard Error 1.16
|
11.7 ETDRS letters
Standard Error 1.09
|
5.2 ETDRS letters
Standard Error 1.19
|
3.3 ETDRS letters
Standard Error 1.13
|
SECONDARY outcome
Timeframe: Baseline, Weeks 32 and 36Population: Treatment-naïve ITT population included all randomized participants who were naïve to IVT anti-VEGF or periocular/IVT corticosteroids treatment. Participants were grouped according to the treatment assigned at randomization.
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=64 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=65 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=65 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=65 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants
|
5.8 ETDRS letters
Standard Error 1.26
|
13.0 ETDRS letters
Standard Error 1.23
|
5.8 ETDRS letters
Standard Error 1.24
|
3.4 ETDRS letters
Standard Error 1.23
|
SECONDARY outcome
Timeframe: Baseline, Weeks 32 and 36Population: Previously treated ITT population included all randomized participants who were previously treated with IVT anti-VEGF or periocular/IVT corticosteroids treatment. Participants were grouped according to the treatment assigned at randomization.
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=34 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=35 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=30 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=36 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants
|
4.4 ETDRS letters
Standard Error 1.20
|
8.5 ETDRS letters
Standard Error 1.12
|
2.0 ETDRS letters
Standard Error 1.31
|
3.4 ETDRS letters
Standard Error 1.14
|
SECONDARY outcome
Timeframe: Baseline, Weeks 32 and 36Population: Overall ITT population included all randomized participants.
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=98 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=100 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=95 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=101 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population
|
5.5 ETDRS letters
Standard Error 0.91
|
11.4 ETDRS letters
Standard Error 0.88
|
4.4 ETDRS letters
Standard Error 0.93
|
3.6 ETDRS letters
Standard Error 0.88
|
SECONDARY outcome
Timeframe: Baseline, Weeks 20 and 24Population: Treatment-naïve ITT population included all randomized participants who were naïve to IVT anti-VEGF or periocular/IVT corticosteroids treatment. Participants were grouped according to the treatment assigned at randomization.
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=64 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=65 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=65 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=65 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants
|
5.3 ETDRS letters
Standard Error 1.20
|
11.1 ETDRS letters
Standard Error 1.19
|
6.4 ETDRS letters
Standard Error 1.19
|
3.5 ETDRS letters
Standard Error 1.18
|
SECONDARY outcome
Timeframe: Baseline, Weeks 20 and 24Population: Previously treated ITT population included all randomized participants who were previously treated with IVT anti-VEGF or periocular/IVT corticosteroids treatment. Participants were grouped according to the treatment assigned at randomization.
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=34 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=35 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=30 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=36 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants
|
5.4 ETDRS letters
Standard Error 1.22
|
8.4 ETDRS letters
Standard Error 1.18
|
2.7 ETDRS letters
Standard Error 1.36
|
2.8 ETDRS letters
Standard Error 1.19
|
SECONDARY outcome
Timeframe: Baseline, Weeks 20 and 24Population: Overall ITT population included all randomized participants.
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=98 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=100 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=95 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=101 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population
|
5.4 ETDRS letters
Standard Error 0.89
|
10.2 ETDRS letters
Standard Error 0.88
|
5.1 ETDRS letters
Standard Error 0.92
|
3.3 ETDRS letters
Standard Error 0.87
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72Population: Overall ITT population included all randomized participants. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=98 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=100 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=95 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=101 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Change From Baseline in BCVA Over Time, in Overall Enrolled Population
Change at Week 4
|
3.8 ETDRS letters
Standard Error 0.64
|
6.2 ETDRS letters
Standard Error 0.63
|
3.0 ETDRS letters
Standard Error 0.65
|
2.3 ETDRS letters
Standard Error 0.63
|
|
Change From Baseline in BCVA Over Time, in Overall Enrolled Population
Change at Week 8
|
5.1 ETDRS letters
Standard Error 0.66
|
7.6 ETDRS letters
Standard Error 0.66
|
4.3 ETDRS letters
Standard Error 0.68
|
3.3 ETDRS letters
Standard Error 0.65
|
|
Change From Baseline in BCVA Over Time, in Overall Enrolled Population
Change at Week 12
|
4.6 ETDRS letters
Standard Error 0.84
|
8.2 ETDRS letters
Standard Error 0.83
|
4.4 ETDRS letters
Standard Error 0.87
|
4.2 ETDRS letters
Standard Error 0.82
|
|
Change From Baseline in BCVA Over Time, in Overall Enrolled Population
Change at Week 16
|
5.0 ETDRS letters
Standard Error 0.83
|
9.1 ETDRS letters
Standard Error 0.83
|
4.5 ETDRS letters
Standard Error 0.85
|
3.7 ETDRS letters
Standard Error 0.81
|
|
Change From Baseline in BCVA Over Time, in Overall Enrolled Population
Change at Week 20
|
5.0 ETDRS letters
Standard Error 0.95
|
10.2 ETDRS letters
Standard Error 0.93
|
5.2 ETDRS letters
Standard Error 0.98
|
3.5 ETDRS letters
Standard Error 0.92
|
|
Change From Baseline in BCVA Over Time, in Overall Enrolled Population
Change at Week 24
|
5.9 ETDRS letters
Standard Error 0.90
|
10.3 ETDRS letters
Standard Error 0.89
|
5.0 ETDRS letters
Standard Error 0.93
|
3.2 ETDRS letters
Standard Error 0.88
|
|
Change From Baseline in BCVA Over Time, in Overall Enrolled Population
Change at Week 28
|
5.3 ETDRS letters
Standard Error 0.93
|
10.6 ETDRS letters
Standard Error 0.91
|
4.6 ETDRS letters
Standard Error 0.95
|
3.1 ETDRS letters
Standard Error 0.90
|
|
Change From Baseline in BCVA Over Time, in Overall Enrolled Population
Change at Week 32
|
5.8 ETDRS letters
Standard Error 0.94
|
11.3 ETDRS letters
Standard Error 0.90
|
4.5 ETDRS letters
Standard Error 0.95
|
3.4 ETDRS letters
Standard Error 0.90
|
|
Change From Baseline in BCVA Over Time, in Overall Enrolled Population
Change at Week 36
|
5.2 ETDRS letters
Standard Error 0.96
|
11.4 ETDRS letters
Standard Error 0.92
|
4.2 ETDRS letters
Standard Error 0.98
|
3.6 ETDRS letters
Standard Error 0.92
|
|
Change From Baseline in BCVA Over Time, in Overall Enrolled Population
Change at Week 40
|
4.5 ETDRS letters
Standard Error 1.22
|
11.8 ETDRS letters
Standard Error 1.14
|
4.7 ETDRS letters
Standard Error 1.25
|
2.3 ETDRS letters
Standard Error 1.19
|
|
Change From Baseline in BCVA Over Time, in Overall Enrolled Population
Change at Week 44
|
4.3 ETDRS letters
Standard Error 1.19
|
11.7 ETDRS letters
Standard Error 1.12
|
5.3 ETDRS letters
Standard Error 1.22
|
3.5 ETDRS letters
Standard Error 1.16
|
|
Change From Baseline in BCVA Over Time, in Overall Enrolled Population
Change at Week 48
|
3.2 ETDRS letters
Standard Error 1.19
|
11.5 ETDRS letters
Standard Error 1.11
|
4.9 ETDRS letters
Standard Error 1.22
|
2.9 ETDRS letters
Standard Error 1.16
|
|
Change From Baseline in BCVA Over Time, in Overall Enrolled Population
Change at Week 52
|
4.7 ETDRS letters
Standard Error 1.07
|
10.4 ETDRS letters
Standard Error 1.01
|
4.8 ETDRS letters
Standard Error 1.11
|
4.1 ETDRS letters
Standard Error 1.05
|
|
Change From Baseline in BCVA Over Time, in Overall Enrolled Population
Change at Week 56
|
4.1 ETDRS letters
Standard Error 1.30
|
9.8 ETDRS letters
Standard Error 1.20
|
4.3 ETDRS letters
Standard Error 1.34
|
2.5 ETDRS letters
Standard Error 1.26
|
|
Change From Baseline in BCVA Over Time, in Overall Enrolled Population
Change at Week 60
|
3.3 ETDRS letters
Standard Error 1.37
|
8.8 ETDRS letters
Standard Error 1.25
|
4.3 ETDRS letters
Standard Error 1.41
|
3.5 ETDRS letters
Standard Error 1.32
|
|
Change From Baseline in BCVA Over Time, in Overall Enrolled Population
Change at Week 64
|
2.4 ETDRS letters
Standard Error 1.40
|
9.2 ETDRS letters
Standard Error 1.30
|
4.8 ETDRS letters
Standard Error 1.45
|
3.7 ETDRS letters
Standard Error 1.35
|
|
Change From Baseline in BCVA Over Time, in Overall Enrolled Population
Change at Week 68
|
2.9 ETDRS letters
Standard Error 1.32
|
9.7 ETDRS letters
Standard Error 1.22
|
5.6 ETDRS letters
Standard Error 1.36
|
4.2 ETDRS letters
Standard Error 1.28
|
|
Change From Baseline in BCVA Over Time, in Overall Enrolled Population
Change at Week 72
|
2.9 ETDRS letters
Standard Error 1.35
|
9.2 ETDRS letters
Standard Error 1.24
|
4.5 ETDRS letters
Standard Error 1.39
|
3.6 ETDRS letters
Standard Error 1.29
|
SECONDARY outcome
Timeframe: From baseline up to Week 72Population: Overall ITT population included all randomized participants. Overall number analyzed is the number of participants with data available for analysis.
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=98 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=98 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=94 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=100 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Percentage of Participants Gaining Greater Than or Equal to (≥) 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population
Participants gaining ≥ 0 Letters
|
99.0 percentage of participants
|
100 percentage of participants
|
97.9 percentage of participants
|
98.0 percentage of participants
|
|
Percentage of Participants Gaining Greater Than or Equal to (≥) 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population
Participants gaining ≥ 5 Letters
|
76.5 percentage of participants
|
94.9 percentage of participants
|
79.8 percentage of participants
|
83.0 percentage of participants
|
|
Percentage of Participants Gaining Greater Than or Equal to (≥) 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population
Participants gaining ≥ 10 Letters
|
56.1 percentage of participants
|
75.5 percentage of participants
|
51.1 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants Gaining Greater Than or Equal to (≥) 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population
Participants gaining ≥ 15 Letters
|
34.7 percentage of participants
|
58.2 percentage of participants
|
26.6 percentage of participants
|
28.0 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline up to Week 72Population: Overall ITT population included all randomized participants. Overall number analyzed is the number of participants with data available for analysis.
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=98 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=98 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=94 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=100 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population
Participants avoiding a loss of ≥ 5 Letters
|
64.3 percentage of participants
|
83.7 percentage of participants
|
70.2 percentage of participants
|
61.0 percentage of participants
|
|
Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population
Participants avoiding a loss of ≥ 10 Letters
|
87.8 percentage of participants
|
93.9 percentage of participants
|
85.1 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population
Participants avoiding a loss of ≥ 15 Letters
|
89.8 percentage of participants
|
95.9 percentage of participants
|
92.6 percentage of participants
|
87.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Overall ITT population included all randomized participants. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 (Snellen equivalent \<20/800) to 100 (Snellen equivalent of 20/10) letters. A gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=98 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=100 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=95 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=101 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
Baseline
|
43.9 percentage of participants
|
35.0 percentage of participants
|
34.7 percentage of participants
|
32.7 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 1
|
53.7 percentage of participants
|
53.6 percentage of participants
|
45.6 percentage of participants
|
44.3 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 4
|
55.3 percentage of participants
|
65.6 percentage of participants
|
50.6 percentage of participants
|
49.5 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 8
|
63.3 percentage of participants
|
73.1 percentage of participants
|
56.5 percentage of participants
|
46.9 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 12
|
63.2 percentage of participants
|
78.3 percentage of participants
|
59.0 percentage of participants
|
51.0 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 16
|
61.8 percentage of participants
|
77.3 percentage of participants
|
57.8 percentage of participants
|
52.2 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 20
|
61.4 percentage of participants
|
79.1 percentage of participants
|
62.8 percentage of participants
|
50.5 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 24
|
65.0 percentage of participants
|
83.5 percentage of participants
|
64.5 percentage of participants
|
52.9 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 28
|
68.9 percentage of participants
|
77.4 percentage of participants
|
63.5 percentage of participants
|
52.9 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 32
|
67.2 percentage of participants
|
81.6 percentage of participants
|
71.0 percentage of participants
|
51.9 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 36
|
66.7 percentage of participants
|
84.3 percentage of participants
|
65.2 percentage of participants
|
53.8 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 40
|
72.1 percentage of participants
|
81.7 percentage of participants
|
64.6 percentage of participants
|
57.1 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 44
|
69.7 percentage of participants
|
84.0 percentage of participants
|
68.8 percentage of participants
|
62.0 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 48
|
57.6 percentage of participants
|
84.3 percentage of participants
|
67.8 percentage of participants
|
62.7 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 52
|
65.6 percentage of participants
|
75.6 percentage of participants
|
66.0 percentage of participants
|
61.3 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 56
|
73.6 percentage of participants
|
77.6 percentage of participants
|
78.7 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 60
|
76.0 percentage of participants
|
80.6 percentage of participants
|
67.4 percentage of participants
|
58.2 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 64
|
72.9 percentage of participants
|
83.3 percentage of participants
|
75.6 percentage of participants
|
57.4 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 68
|
65.9 percentage of participants
|
84.9 percentage of participants
|
70.0 percentage of participants
|
58.3 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 72
|
74.4 percentage of participants
|
83.0 percentage of participants
|
67.6 percentage of participants
|
66.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Overall ITT population included all randomized participants. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 (Snellen equivalent \<20/800) to 100 (Snellen equivalent of 20/10) letters. A gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=98 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=100 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=95 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=101 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
Baseline
|
0 percentage of participants
|
1.0 percentage of participants
|
1.1 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 1
|
0 percentage of participants
|
6.2 percentage of participants
|
2.2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 4
|
4.3 percentage of participants
|
3.1 percentage of participants
|
4.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 8
|
5.6 percentage of participants
|
5.4 percentage of participants
|
3.5 percentage of participants
|
5.2 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 12
|
8.0 percentage of participants
|
6.5 percentage of participants
|
6.4 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 16
|
11.2 percentage of participants
|
9.1 percentage of participants
|
7.2 percentage of participants
|
3.3 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 20
|
12.0 percentage of participants
|
14.3 percentage of participants
|
5.1 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 24
|
12.5 percentage of participants
|
15.3 percentage of participants
|
7.9 percentage of participants
|
4.7 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 28
|
8.1 percentage of participants
|
14.3 percentage of participants
|
5.4 percentage of participants
|
7.1 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 32
|
10.4 percentage of participants
|
20.7 percentage of participants
|
10.1 percentage of participants
|
8.9 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 36
|
8.7 percentage of participants
|
15.7 percentage of participants
|
5.8 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 40
|
11.8 percentage of participants
|
19.5 percentage of participants
|
7.7 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 44
|
12.1 percentage of participants
|
21.0 percentage of participants
|
12.5 percentage of participants
|
12.7 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 48
|
12.1 percentage of participants
|
16.9 percentage of participants
|
6.8 percentage of participants
|
9.0 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 52
|
17.2 percentage of participants
|
19.5 percentage of participants
|
5.7 percentage of participants
|
14.5 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 56
|
18.9 percentage of participants
|
18.4 percentage of participants
|
10.6 percentage of participants
|
11.7 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 60
|
18.0 percentage of participants
|
20.9 percentage of participants
|
13.0 percentage of participants
|
12.7 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 64
|
18.8 percentage of participants
|
22.2 percentage of participants
|
17.1 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 68
|
15.9 percentage of participants
|
26.4 percentage of participants
|
15.0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
Week 72
|
17.9 percentage of participants
|
25.5 percentage of participants
|
13.5 percentage of participants
|
12.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Overall ITT population included all randomized participants. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 (Snellen equivalent \<20/800) to 100 (Snellen equivalent of 20/10) letters. A gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=98 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=100 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=95 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=101 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
Baseline
|
1.0 percentage of participants
|
1.0 percentage of participants
|
1.1 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
Week 1
|
1.1 percentage of participants
|
0 percentage of participants
|
2.2 percentage of participants
|
3.1 percentage of participants
|
|
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
Week 4
|
1.1 percentage of participants
|
0 percentage of participants
|
1.1 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
Week 8
|
0 percentage of participants
|
0 percentage of participants
|
1.2 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
Week 12
|
1.1 percentage of participants
|
0 percentage of participants
|
1.3 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
Week 16
|
2.2 percentage of participants
|
1.1 percentage of participants
|
1.2 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
Week 20
|
3.6 percentage of participants
|
0 percentage of participants
|
1.3 percentage of participants
|
3.3 percentage of participants
|
|
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
Week 24
|
1.3 percentage of participants
|
0 percentage of participants
|
1.3 percentage of participants
|
2.4 percentage of participants
|
|
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
Week 28
|
1.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
2.4 percentage of participants
|
|
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
Week 32
|
1.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
Week 36
|
2.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
Week 40
|
4.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
1.4 percentage of participants
|
|
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
Week 44
|
3.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
Week 48
|
3.0 percentage of participants
|
0 percentage of participants
|
1.7 percentage of participants
|
1.5 percentage of participants
|
|
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
Week 52
|
1.6 percentage of participants
|
0 percentage of participants
|
3.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
Week 56
|
3.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
1.7 percentage of participants
|
|
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
Week 60
|
4.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
Week 64
|
4.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
1.9 percentage of participants
|
|
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
Week 68
|
2.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
Week 72
|
5.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
2.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 44 and 48Population: Treatment-naïve ITT population included all randomized participants who were naïve to IVT anti-VEGF or periocular/IVT corticosteroids treatment. Participants were grouped according to the treatment assigned at randomization.
CST was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE), measured using Spectral Domain-Optical Coherence Tomography (SD-OCT). This analysis used a MMRM model. Adjusted mean has been reported.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=64 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=65 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=65 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=65 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Change From Baseline in Central Subfield Thickness (CST) Averaged Over Weeks 44 and 48, in Treatment-naïve Participants
|
-67.5 micrometers (µm)
Standard Error 14.44
|
-174.2 micrometers (µm)
Standard Error 13.95
|
-68.4 micrometers (µm)
Standard Error 14.23
|
-50.8 micrometers (µm)
Standard Error 14.18
|
SECONDARY outcome
Timeframe: Baseline, Weeks 44 and 48Population: Previously treated ITT population included all randomized participants who were previously treated with IVT anti-VEGF or periocular/IVT corticosteroids. Participants were grouped according to the treatment assigned at randomization.
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=34 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=35 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=30 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=36 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Change From Baseline in CST Averaged Over Weeks 44 and 48, in Previously Treated Participants
|
-75.8 µm
Standard Error 20.44
|
-185.7 µm
Standard Error 18.54
|
-40.9 µm
Standard Error 22.14
|
-81.4 µm
Standard Error 19.39
|
SECONDARY outcome
Timeframe: Baseline, Weeks 44 and 48Population: Overall ITT population included all randomized participants.
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=98 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=100 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=95 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=101 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Change From Baseline in CST Averaged Over Weeks 44 and 48, in Overall Enrolled Population
|
-70.5 µm
Standard Error 11.97
|
-176.9 µm
Standard Error 11.32
|
-57.3 µm
Standard Error 12.14
|
-61.1 µm
Standard Error 11.64
|
SECONDARY outcome
Timeframe: Baseline, Weeks 32 and 36Population: Treatment-naïve ITT population included all randomized participants who were naïve to IVT anti-VEGF or periocular/IVT corticosteroids treatment. Participants were grouped according to the treatment assigned at randomization.
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=64 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=65 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=65 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=65 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Change From Baseline in CST Averaged Over Weeks 32 and 36, in Treatment-naïve Participants
|
-64.8 µm
Standard Error 14.22
|
-163.9 µm
Standard Error 13.87
|
-57.1 µm
Standard Error 14.02
|
-46.9 µm
Standard Error 13.94
|
SECONDARY outcome
Timeframe: Baseline, Weeks 32 and 36Population: Previously treated ITT population included all randomized participants who were previously treated with IVT anti-VEGF or periocular/IVT corticosteroids. Participants were grouped according to the treatment assigned at randomization.
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=34 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=35 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=30 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=36 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Change From Baseline in CST Averaged Over Weeks 32 and 36, in Previously Treated Participants
|
-81.5 µm
Standard Error 18.34
|
-168.5 µm
Standard Error 17.10
|
-35.4 µm
Standard Error 19.87
|
-90.5 µm
Standard Error 17.45
|
SECONDARY outcome
Timeframe: Baseline, Weeks 32 and 36Population: Overall ITT population included all randomized participants.
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=98 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=100 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=95 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=101 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Change From Baseline in CST Averaged Over Weeks 32 and 36, in Overall Enrolled Population
|
-69.4 µm
Standard Error 11.41
|
-164.8 µm
Standard Error 10.95
|
-47.6 µm
Standard Error 11.57
|
-62.1 µm
Standard Error 11.09
|
SECONDARY outcome
Timeframe: Baseline, Weeks 20 and 24Population: Treatment-naïve ITT population included all randomized participants who were naïve to IVT anti-VEGF or periocular/IVT corticosteroids. Participants were grouped according to the treatment assigned at randomization.
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=64 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=65 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=65 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=65 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Change From Baseline in CST Averaged Over Weeks 20 and 24, in Treatment-naïve Participants
|
-68.5 µm
Standard Error 11.62
|
-150.4 µm
Standard Error 11.56
|
-48.5 µm
Standard Error 11.61
|
-68.8 µm
Standard Error 11.53
|
SECONDARY outcome
Timeframe: Baseline, Weeks 20 and 24Population: Previously treated ITT population included all randomized participants who were previously treated with IVT anti-VEGF or periocular/IVT corticosteroids. Participants were grouped according to the treatment assigned at randomization.
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=34 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=35 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=30 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=36 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Change From Baseline in CST Averaged Over Weeks 20 and 24, in Previously Treated Participants
|
-68.7 µm
Standard Error 19.22
|
-146.4 µm
Standard Error 18.47
|
-5.7 µm
Standard Error 20.88
|
-81.7 µm
Standard Error 18.67
|
SECONDARY outcome
Timeframe: Baseline, Weeks 20 and 24Population: Overall ITT population included all randomized participants.
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=98 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=100 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=95 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=101 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Change From Baseline in CST Averaged Over Weeks 20 and 24, in Overall Enrolled Population
|
-69.0 µm
Standard Error 10.01
|
-148.1 µm
Standard Error 9.86
|
-36.1 µm
Standard Error 10.28
|
-72.9 µm
Standard Error 9.88
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72Population: Overall ITT population included all randomized participants. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=98 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=100 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=95 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=101 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Change From Baseline in CST Over Time, in Overall Enrolled Population
Change at Week 52
|
-89.6 µm
Standard Error 13.01
|
-112.4 µm
Standard Error 11.92
|
-63.4 µm
Standard Error 13.52
|
-72.0 µm
Standard Error 12.89
|
|
Change From Baseline in CST Over Time, in Overall Enrolled Population
Change at Week 56
|
-74.6 µm
Standard Error 14.36
|
-107.3 µm
Standard Error 12.66
|
-67.6 µm
Standard Error 14.94
|
-81.6 µm
Standard Error 13.84
|
|
Change From Baseline in CST Over Time, in Overall Enrolled Population
Change at Week 60
|
-81.5 µm
Standard Error 13.69
|
-111.0 µm
Standard Error 12.34
|
-73.9 µm
Standard Error 14.17
|
-77.2 µm
Standard Error 13.41
|
|
Change From Baseline in CST Over Time, in Overall Enrolled Population
Change at Week 64
|
-81.1 µm
Standard Error 13.65
|
-112.5 µm
Standard Error 12.48
|
-66.1 µm
Standard Error 14.20
|
-66.3 µm
Standard Error 13.31
|
|
Change From Baseline in CST Over Time, in Overall Enrolled Population
Change at Week 68
|
-65.4 µm
Standard Error 14.13
|
-115.2 µm
Standard Error 12.87
|
-73.2 µm
Standard Error 14.64
|
-88.8 µm
Standard Error 13.81
|
|
Change From Baseline in CST Over Time, in Overall Enrolled Population
Change at Week 72
|
-78.8 µm
Standard Error 13.83
|
-113.1 µm
Standard Error 12.61
|
-73.9 µm
Standard Error 14.28
|
-81.9 µm
Standard Error 13.45
|
|
Change From Baseline in CST Over Time, in Overall Enrolled Population
Change at Week 8
|
-50.9 µm
Standard Error 8.87
|
-130.7 µm
Standard Error 8.76
|
-31.2 µm
Standard Error 9.02
|
-34.0 µm
Standard Error 8.76
|
|
Change From Baseline in CST Over Time, in Overall Enrolled Population
Change at Week 12
|
-56.3 µm
Standard Error 9.41
|
-131.4 µm
Standard Error 9.27
|
-38.4 µm
Standard Error 9.66
|
-52.9 µm
Standard Error 9.27
|
|
Change From Baseline in CST Over Time, in Overall Enrolled Population
Change at Week 16
|
-59.5 µm
Standard Error 10.16
|
-138.8 µm
Standard Error 10.08
|
-39.3 µm
Standard Error 10.43
|
-55.0 µm
Standard Error 10.06
|
|
Change From Baseline in CST Over Time, in Overall Enrolled Population
Change at Week 20
|
-64.0 µm
Standard Error 10.59
|
-139.9 µm
Standard Error 10.41
|
-37.9 µm
Standard Error 10.88
|
-71.5 µm
Standard Error 10.44
|
|
Change From Baseline in CST Over Time, in Overall Enrolled Population
Change at Week 24
|
-69.7 µm
Standard Error 10.46
|
-152.4 µm
Standard Error 10.27
|
-30.7 µm
Standard Error 10.73
|
-71.4 µm
Standard Error 10.31
|
|
Change From Baseline in CST Over Time, in Overall Enrolled Population
Change at Week 28
|
-67.3 µm
Standard Error 11.14
|
-158.9 µm
Standard Error 10.81
|
-47.3 µm
Standard Error 11.36
|
-66.7 µm
Standard Error 10.87
|
|
Change From Baseline in CST Over Time, in Overall Enrolled Population
Change at Week 32
|
-69.6 µm
Standard Error 11.66
|
-159.2 µm
Standard Error 11.18
|
-47.2 µm
Standard Error 11.82
|
-59.6 µm
Standard Error 11.33
|
|
Change From Baseline in CST Over Time, in Overall Enrolled Population
Change at Week 36
|
-64.8 µm
Standard Error 11.93
|
-166.8 µm
Standard Error 11.40
|
-44.2 µm
Standard Error 12.07
|
-61.6 µm
Standard Error 11.56
|
|
Change From Baseline in CST Over Time, in Overall Enrolled Population
Change at Week 40
|
-69.7 µm
Standard Error 12.34
|
-164.2 µm
Standard Error 11.74
|
-50.3 µm
Standard Error 12.51
|
-56.1 µm
Standard Error 12.03
|
|
Change From Baseline in CST Over Time, in Overall Enrolled Population
Change at Week 44
|
-73.6 µm
Standard Error 12.11
|
-174.4 µm
Standard Error 11.44
|
-53.5 µm
Standard Error 12.26
|
-56.4 µm
Standard Error 11.75
|
|
Change From Baseline in CST Over Time, in Overall Enrolled Population
Change at Week 48
|
-63.1 µm
Standard Error 12.52
|
-176.2 µm
Standard Error 11.82
|
-58.4 µm
Standard Error 12.76
|
-62.2 µm
Standard Error 12.24
|
|
Change From Baseline in CST Over Time, in Overall Enrolled Population
Change at Week 4
|
-36.3 µm
Standard Error 7.93
|
-106.9 µm
Standard Error 7.83
|
-25.7 µm
Standard Error 8.06
|
-26.6 µm
Standard Error 7.88
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72Population: Overall ITT population included all randomized participants. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Absence of DME was defined as CST \< 325 µm for spectralis SD-OCT, or \< 315 μm for cirrus SD-OCT or topcon SD-OCT. SD-OCT was performed on a Spectralis instrument. Percentages have been summarized.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=98 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=100 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=95 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=101 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
Baseline
|
4.1 percentage of participants
Interval 0.2 to 8.1
|
6.0 percentage of participants
Interval 1.3 to 10.7
|
3.2 percentage of participants
Interval 0.0 to 6.7
|
1.0 percentage of participants
Interval 0.0 to 3.0
|
|
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
Week 8
|
17.8 percentage of participants
Interval 9.9 to 25.7
|
53.3 percentage of participants
Interval 43.1 to 63.5
|
10.6 percentage of participants
Interval 4.0 to 17.1
|
12.5 percentage of participants
Interval 5.9 to 19.1
|
|
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
Week 12
|
24.1 percentage of participants
Interval 15.1 to 33.1
|
53.3 percentage of participants
Interval 43.1 to 63.5
|
8.9 percentage of participants
Interval 2.6 to 15.1
|
18.9 percentage of participants
Interval 11.1 to 26.8
|
|
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
Week 16
|
25.8 percentage of participants
Interval 16.7 to 34.9
|
61.4 percentage of participants
Interval 51.2 to 71.5
|
12.0 percentage of participants
Interval 5.0 to 19.1
|
16.3 percentage of participants
Interval 8.8 to 23.9
|
|
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
Week 20
|
30.1 percentage of participants
Interval 20.3 to 40.0
|
64.4 percentage of participants
Interval 54.6 to 74.3
|
19.2 percentage of participants
Interval 10.5 to 28.0
|
27.8 percentage of participants
Interval 18.5 to 37.0
|
|
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
Week 4
|
13.8 percentage of participants
Interval 6.9 to 20.8
|
35.4 percentage of participants
Interval 25.8 to 45.0
|
6.8 percentage of participants
Interval 1.6 to 12.1
|
8.4 percentage of participants
Interval 2.8 to 14.0
|
|
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
Week 28
|
33.8 percentage of participants
Interval 23.0 to 44.6
|
73.8 percentage of participants
Interval 64.4 to 83.2
|
24.7 percentage of participants
Interval 14.8 to 34.5
|
29.4 percentage of participants
Interval 19.7 to 39.1
|
|
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
Week 32
|
34.3 percentage of participants
Interval 23.0 to 45.7
|
75.9 percentage of participants
Interval 66.9 to 84.9
|
35.7 percentage of participants
Interval 24.5 to 46.9
|
28.8 percentage of participants
Interval 18.8 to 38.7
|
|
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
Week 24
|
26.3 percentage of participants
Interval 16.6 to 35.9
|
70.6 percentage of participants
Interval 60.9 to 80.3
|
17.1 percentage of participants
Interval 8.6 to 25.6
|
25.9 percentage of participants
Interval 16.6 to 35.2
|
|
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
Week 36
|
35.3 percentage of participants
Interval 23.9 to 46.7
|
79.5 percentage of participants
Interval 70.8 to 88.2
|
30.0 percentage of participants
Interval 19.3 to 40.7
|
31.3 percentage of participants
Interval 21.1 to 41.4
|
|
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
Week 40
|
35.3 percentage of participants
Interval 23.9 to 46.7
|
78.0 percentage of participants
Interval 69.1 to 87.0
|
33.3 percentage of participants
Interval 22.0 to 44.7
|
27.1 percentage of participants
Interval 16.7 to 37.6
|
|
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
Week 44
|
35.4 percentage of participants
Interval 23.8 to 47.0
|
80.2 percentage of participants
Interval 71.6 to 88.9
|
34.4 percentage of participants
Interval 22.7 to 46.0
|
33.8 percentage of participants
Interval 22.8 to 44.8
|
|
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
Week 48
|
30.8 percentage of participants
Interval 19.5 to 42.0
|
79.5 percentage of participants
Interval 70.8 to 88.2
|
41.7 percentage of participants
Interval 29.2 to 54.1
|
35.8 percentage of participants
Interval 24.3 to 47.3
|
|
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
Week 60
|
50.0 percentage of participants
Interval 36.1 to 63.9
|
61.2 percentage of participants
Interval 49.5 to 72.9
|
47.8 percentage of participants
Interval 33.4 to 62.3
|
41.8 percentage of participants
Interval 28.8 to 54.9
|
|
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
Week 64
|
47.9 percentage of participants
Interval 33.8 to 62.0
|
61.8 percentage of participants
Interval 49.0 to 74.7
|
48.8 percentage of participants
Interval 33.5 to 64.1
|
48.1 percentage of participants
Interval 34.8 to 61.5
|
|
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
Week 52
|
36.5 percentage of participants
Interval 24.6 to 48.4
|
54.9 percentage of participants
Interval 44.1 to 65.6
|
35.8 percentage of participants
Interval 22.9 to 48.8
|
39.3 percentage of participants
Interval 27.1 to 51.6
|
|
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
Week 56
|
45.3 percentage of participants
Interval 31.9 to 58.7
|
59.7 percentage of participants
Interval 48.8 to 70.7
|
36.2 percentage of participants
Interval 22.4 to 49.9
|
41.7 percentage of participants
Interval 29.2 to 54.1
|
|
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
Week 68
|
48.8 percentage of participants
Interval 33.9 to 63.8
|
62.3 percentage of participants
Interval 49.2 to 75.3
|
45.0 percentage of participants
Interval 29.6 to 60.4
|
51.1 percentage of participants
Interval 36.8 to 65.4
|
|
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
Week 72
|
48.7 percentage of participants
Interval 33.0 to 64.4
|
60.9 percentage of participants
Interval 46.8 to 75.0
|
43.2 percentage of participants
Interval 27.3 to 59.2
|
42.6 percentage of participants
Interval 28.4 to 56.7
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 24, 36, 48, and 72Population: Overall ITT population included all randomized participants. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
The absence of IRF in the study eye (defined as IRF absent or definite outside center subfield only) was assessed by the central reading center using SD-OCT. The percentage of participants with the absence of IRF at the foveal center were reported. Percentages have been summarized.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=98 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=100 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=95 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=101 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time, in Overall Enrolled Population
Week 48
|
44.4 percentage of participants
|
77.8 percentage of participants
|
49.2 percentage of participants
|
47.8 percentage of participants
|
|
Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time, in Overall Enrolled Population
Week 72
|
61.5 percentage of participants
|
76.1 percentage of participants
|
62.2 percentage of participants
|
55.3 percentage of participants
|
|
Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time, in Overall Enrolled Population
Week 24
|
53.8 percentage of participants
|
64.3 percentage of participants
|
34.7 percentage of participants
|
45.2 percentage of participants
|
|
Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time, in Overall Enrolled Population
Week 36
|
43.9 percentage of participants
|
84.0 percentage of participants
|
42.4 percentage of participants
|
43.6 percentage of participants
|
|
Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time, in Overall Enrolled Population
Baseline
|
24.7 percentage of participants
|
25.0 percentage of participants
|
22.1 percentage of participants
|
15.2 percentage of participants
|
|
Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time, in Overall Enrolled Population
Week 4
|
32.3 percentage of participants
|
46.9 percentage of participants
|
21.6 percentage of participants
|
26.6 percentage of participants
|
|
Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time, in Overall Enrolled Population
Week 12
|
38.1 percentage of participants
|
56.0 percentage of participants
|
33.8 percentage of participants
|
40.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 24, 36, 48, and 72Population: Overall ITT population included all randomized participants. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
The absence of SRF in the study eye (defined as SRF absent or definite outside center subfield only) was assessed by the central reading center using SD-OCT. The percentage of participants with absence of SRF at the foveal center were reported. Percentages have been summarized.
Outcome measures
| Measure |
Arm C: Vamikibart 1 mg Q4W
n=98 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=100 Participants
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm A: Vamikibart 0.25 mg Q8W
n=95 Participants
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=101 Participants
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time, in Overall ITT Population
Baseline
|
68.0 percentage of participants
|
67.0 percentage of participants
|
62.1 percentage of participants
|
61.6 percentage of participants
|
|
Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time, in Overall ITT Population
Week 12
|
87.1 percentage of participants
|
96.7 percentage of participants
|
81.8 percentage of participants
|
77.9 percentage of participants
|
|
Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time, in Overall ITT Population
Week 4
|
82.8 percentage of participants
|
85.4 percentage of participants
|
70.5 percentage of participants
|
71.6 percentage of participants
|
|
Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time, in Overall ITT Population
Week 24
|
88.6 percentage of participants
|
97.6 percentage of participants
|
84.0 percentage of participants
|
89.3 percentage of participants
|
|
Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time, in Overall ITT Population
Week 36
|
93.9 percentage of participants
|
100 percentage of participants
|
87.9 percentage of participants
|
89.7 percentage of participants
|
|
Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time, in Overall ITT Population
Week 48
|
93.7 percentage of participants
|
98.8 percentage of participants
|
89.8 percentage of participants
|
91.0 percentage of participants
|
|
Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time, in Overall ITT Population
Week 72
|
97.4 percentage of participants
|
95.7 percentage of participants
|
94.6 percentage of participants
|
93.6 percentage of participants
|
Adverse Events
Arm A: Vamikibart 0.25 mg Q8W
Serious events: 17 serious events
Other events: 25 other events
Deaths: 1 deaths
Arm B: Vamikibart 1 mg Q8W
Serious events: 25 serious events
Other events: 40 other events
Deaths: 1 deaths
Arm C: Vamikibart 1 mg Q4W
Serious events: 21 serious events
Other events: 36 other events
Deaths: 1 deaths
Arm D: Ranibizumab 0.5 mg Q4W
Serious events: 20 serious events
Other events: 32 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm A: Vamikibart 0.25 mg Q8W
n=94 participants at risk
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=100 participants at risk
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm C: Vamikibart 1 mg Q4W
n=98 participants at risk
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=98 participants at risk
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/100 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Cardiac disorders
Myocardial infarction
|
2.1%
2/94 • Number of events 3 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Cardiac disorders
Ventricular extrasystoles
|
1.1%
1/94 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Eye disorders
Bullous keratopathy
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/100 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Eye disorders
Eye inflammation
|
1.1%
1/94 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
2.0%
2/100 • Number of events 2 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Eye disorders
Glaucoma
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Eye disorders
Iridocyclitis
|
1.1%
1/94 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Eye disorders
Ocular vasculitis
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/100 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Eye disorders
Retinal occlusive vasculitis
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
2.0%
2/98 • Number of events 2 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
1.1%
1/94 • Number of events 2 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Eye disorders
Tractional retinal detachment
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Eye disorders
Uveitis
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/100 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
3.1%
3/98 • Number of events 5 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/100 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
3.0%
3/100 • Number of events 3 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
2.0%
2/98 • Number of events 2 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Eye disorders
Vitritis
|
1.1%
1/94 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Gastrointestinal disorders
Colitis
|
1.1%
1/94 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Gastrointestinal disorders
Hernial eventration
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
General disorders
Chest pain
|
1.1%
1/94 • Number of events 2 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
General disorders
Death
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
General disorders
Generalised oedema
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/100 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.1%
1/94 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/100 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Infections and infestations
COVID-19
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Infections and infestations
Chorioretinitis
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Infections and infestations
Corneal abscess
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/100 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Infections and infestations
Eye infection toxoplasmal
|
1.1%
1/94 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Infections and infestations
Infective exacerbation of asthma
|
1.1%
1/94 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Infections and infestations
Influenza
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/100 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Infections and infestations
Localised infection
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/100 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/100 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Investigations
Blood pressure increased
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
4.0%
4/100 • Number of events 4 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Infections and infestations
Sepsis
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 2 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 2 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
2.0%
2/100 • Number of events 2 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
2.0%
2/98 • Number of events 2 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Injury, poisoning and procedural complications
Eye injury
|
1.1%
1/94 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.1%
1/94 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.1%
1/94 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 2 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.1%
1/94 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/100 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/100 • Number of events 2 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/100 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
2.0%
2/100 • Number of events 2 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
3.1%
3/98 • Number of events 3 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/100 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.1%
1/94 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/100 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
2.0%
2/98 • Number of events 2 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
2.0%
2/98 • Number of events 2 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/100 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
1.1%
1/94 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/100 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
2.0%
2/98 • Number of events 2 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/100 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Vascular disorders
Hypertension
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/100 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Vascular disorders
Hypertensive crisis
|
1.1%
1/94 • Number of events 4 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Vascular disorders
Hypotension
|
1.1%
1/94 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/94 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/100 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
1.0%
1/98 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
0.00%
0/98 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
Other adverse events
| Measure |
Arm A: Vamikibart 0.25 mg Q8W
n=94 participants at risk
Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm B: Vamikibart 1 mg Q8W
n=100 participants at risk
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.
|
Arm C: Vamikibart 1 mg Q4W
n=98 participants at risk
Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
Arm D: Ranibizumab 0.5 mg Q4W
n=98 participants at risk
Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.
|
|---|---|---|---|---|
|
Eye disorders
Cataract
|
1.1%
1/94 • Number of events 1 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
7.0%
7/100 • Number of events 9 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
5.1%
5/98 • Number of events 10 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
9.2%
9/98 • Number of events 12 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Eye disorders
Conjunctival haemorrhage
|
6.4%
6/94 • Number of events 6 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
10.0%
10/100 • Number of events 10 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
6.1%
6/98 • Number of events 8 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
6.1%
6/98 • Number of events 9 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Eye disorders
Diabetic retinal oedema
|
7.4%
7/94 • Number of events 7 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
10.0%
10/100 • Number of events 13 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
12.2%
12/98 • Number of events 12 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
5.1%
5/98 • Number of events 6 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Eye disorders
Diabetic retinopathy
|
5.3%
5/94 • Number of events 5 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
2.0%
2/100 • Number of events 2 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
4.1%
4/98 • Number of events 5 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
2.0%
2/98 • Number of events 2 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Eye disorders
Vitreous haemorrhage
|
3.2%
3/94 • Number of events 3 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
6.0%
6/100 • Number of events 7 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
6.1%
6/98 • Number of events 6 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
4.1%
4/98 • Number of events 4 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Infections and infestations
COVID-19
|
2.1%
2/94 • Number of events 2 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
6.0%
6/100 • Number of events 6 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
3.1%
3/98 • Number of events 3 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
4.1%
4/98 • Number of events 4 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
2/94 • Number of events 2 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
2.0%
2/100 • Number of events 2 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
4.1%
4/98 • Number of events 4 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
5.1%
5/98 • Number of events 5 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
|
Vascular disorders
Hypertension
|
6.4%
6/94 • Number of events 6 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
8.0%
8/100 • Number of events 8 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
5.1%
5/98 • Number of events 6 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
7.1%
7/98 • Number of events 7 • From baseline up to 72 weeks
Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received. Ocular AEs included both study eye and fellow eye. 1 participant in each of the Arm A \& B \& 2 participants in Arm D were randomized but not treated. Hence, they were excluded from the safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER