Trial Outcomes & Findings for Clinical Study to Evaluate PRO-169 for Diabetic Macular Edema (NCT NCT05217680)
NCT ID: NCT05217680
Last Updated: 2026-05-26
Results Overview
Best Corrected Visual Acuity will be evaluated according the standardized ETDRS. The mean change between two treatments will be used evaluated as difference between baseline and final (12 months) values.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
509 participants
Primary outcome timeframe
Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit)
Results posted on
2026-05-26
Participant Flow
Participant milestones
| Measure |
PRO-169
Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Bevacizumab: Administration of monthly intravitreal bevacizumab (4-12 injections)
|
Lucentis ®
Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Lucentis®: Administration of monthly intravitreal ranibizumab (4-12 injections)
|
|---|---|---|
|
Overall Study
STARTED
|
255
|
254
|
|
Overall Study
Population by Intention to Treat (ITT)
|
204
|
201
|
|
Overall Study
COMPLETED
|
186
|
189
|
|
Overall Study
NOT COMPLETED
|
69
|
65
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Lucentis ®
n=201 Participants
Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Lucentis®: Administration of monthly intravitreal ranibizumab (4-12 injections)
|
Total
n=405 Participants
Total of all reporting groups
|
PRO-169
n=204 Participants
Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Bevacizumab: Administration of monthly intravitreal bevacizumab (4-12 injections)
|
|---|---|---|---|
|
Age, Continuous
|
61.13 years
STANDARD_DEVIATION 8.5 • n=201 Participants
|
61.90 years
STANDARD_DEVIATION 8.0 • n=405 Participants
|
62.65 years
STANDARD_DEVIATION 7.4 • n=204 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=201 Participants
|
197 Participants
n=405 Participants
|
101 Participants
n=204 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=201 Participants
|
208 Participants
n=405 Participants
|
103 Participants
n=204 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
—
|
|
HbA1c [%]
|
7.30 percentage of HbA1c
STANDARD_DEVIATION 2.0 • n=201 Participants
|
7.29 percentage of HbA1c
STANDARD_DEVIATION 1.0 • n=405 Participants
|
7.28 percentage of HbA1c
STANDARD_DEVIATION 0.9 • n=204 Participants
|
|
BMI
|
27.14 kg/m^2
STANDARD_DEVIATION 4.3 • n=201 Participants
|
27.65 kg/m^2
STANDARD_DEVIATION 4.4 • n=405 Participants
|
28.15 kg/m^2
STANDARD_DEVIATION 4.5 • n=204 Participants
|
|
Waist circumference
|
92.47 centimeters
STANDARD_DEVIATION 13.5 • n=201 Participants
|
93.39 centimeters
STANDARD_DEVIATION 14.93 • n=405 Participants
|
94.29 centimeters
STANDARD_DEVIATION 14.5 • n=204 Participants
|
|
Diabetes mellitus
|
16.15 years
STANDARD_DEVIATION 8.9 • n=201 Participants
|
16.45 years
STANDARD_DEVIATION 8.6 • n=405 Participants
|
16.75 years
STANDARD_DEVIATION 8.3 • n=204 Participants
|
|
Diabetic macular edema
|
1.20 years
STANDARD_DEVIATION 1.5 • n=201 Participants
|
1.14 years
STANDARD_DEVIATION 1.5 • n=405 Participants
|
1.07 years
STANDARD_DEVIATION 1.5 • n=204 Participants
|
|
Best-corrected visual acuity
|
58.01 letters
STANDARD_DEVIATION 13.7 • n=201 Participants
|
58.04 letters
STANDARD_DEVIATION 13.4 • n=405 Participants
|
58.06 letters
STANDARD_DEVIATION 13.0 • n=204 Participants
|
|
Best-corrected visual acuity (LogMAR)
|
0.53 LogMAR
STANDARD_DEVIATION 0.3 • n=201 Participants
|
0.54 LogMAR
STANDARD_DEVIATION 0.3 • n=405 Participants
|
0.54 LogMAR
STANDARD_DEVIATION 0.3 • n=204 Participants
|
|
Central macular thickness
|
427.92 micrometers
STANDARD_DEVIATION 122.7 • n=201 Participants
|
430.87 micrometers
STANDARD_DEVIATION 120.5 • n=405 Participants
|
433.77 micrometers
STANDARD_DEVIATION 118.4 • n=204 Participants
|
|
Central volume of the retina
|
11.62 cubic millimeter
STANDARD_DEVIATION 2.1 • n=201 Participants
|
11.69 cubic millimeter
STANDARD_DEVIATION 2.1 • n=405 Participants
|
11.76 cubic millimeter
STANDARD_DEVIATION 2.2 • n=204 Participants
|
|
Intraocular pressure
|
14.61 millimeters of mercury (mmHg)
STANDARD_DEVIATION 2.1 • n=201 Participants
|
14.39 millimeters of mercury (mmHg)
STANDARD_DEVIATION 2.0 • n=405 Participants
|
14.16 millimeters of mercury (mmHg)
STANDARD_DEVIATION 2.0 • n=204 Participants
|
PRIMARY outcome
Timeframe: Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit)Population: The change was obtained from the corresponding visit with respect to the final visit. That is, the change from the baseline visit to visit 1, from the baseline visit to visit 2.
Best Corrected Visual Acuity will be evaluated according the standardized ETDRS. The mean change between two treatments will be used evaluated as difference between baseline and final (12 months) values.
Outcome measures
| Measure |
PRO-169
n=204 Participants
Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Bevacizumab: Administration of monthly intravitreal bevacizumab (4-12 injections)
|
Lucentis ®
n=201 Participants
Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Lucentis®: Administration of monthly intravitreal ranibizumab (4-12 injections)
|
|---|---|---|
|
Best Corrected Visual Acuity
Visit 2
|
4.89 Letters
Standard Deviation 7.4
|
5.55 Letters
Standard Deviation 8.5
|
|
Best Corrected Visual Acuity
Visit 3
|
7.09 Letters
Standard Deviation 8.1
|
7.71 Letters
Standard Deviation 9.6
|
|
Best Corrected Visual Acuity
Visit 4
|
7.90 Letters
Standard Deviation 8.8
|
8.65 Letters
Standard Deviation 10.0
|
|
Best Corrected Visual Acuity
Visit 5
|
8.68 Letters
Standard Deviation 8.7
|
9.92 Letters
Standard Deviation 10.3
|
|
Best Corrected Visual Acuity
Visit 6
|
8.99 Letters
Standard Deviation 9.0
|
10.70 Letters
Standard Deviation 10.5
|
|
Best Corrected Visual Acuity
Visit 7
|
8.89 Letters
Standard Deviation 8.8
|
11.15 Letters
Standard Deviation 10.9
|
|
Best Corrected Visual Acuity
Visit 8
|
9.38 Letters
Standard Deviation 9.6
|
11.23 Letters
Standard Deviation 10.9
|
|
Best Corrected Visual Acuity
Visit 9
|
9.43 Letters
Standard Deviation 9.6
|
11.68 Letters
Standard Deviation 10.6
|
|
Best Corrected Visual Acuity
Visit 10
|
9.43 Letters
Standard Deviation 9.3
|
12.01 Letters
Standard Deviation 10.9
|
|
Best Corrected Visual Acuity
Visit 11
|
9.91 Letters
Standard Deviation 9.3
|
12.29 Letters
Standard Deviation 11.1
|
|
Best Corrected Visual Acuity
Visit 12
|
10.26 Letters
Standard Deviation 10.0
|
12.71 Letters
Standard Deviation 11.4
|
|
Best Corrected Visual Acuity
Visit 13
|
10.44 Letters
Standard Deviation 10.4
|
12.54 Letters
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit)Population: The analysis of secondary efficacy variables was conducted in the per-protocol population (PP)
Best Corrected Visual Acuity will be evaluated according the standardized ETDRS. The area under the curve of both treatments will be used evaluated as difference between baseline and final (12 months) values.
Outcome measures
| Measure |
PRO-169
n=186 Participants
Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Bevacizumab: Administration of monthly intravitreal bevacizumab (4-12 injections)
|
Lucentis ®
n=189 Participants
Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Lucentis®: Administration of monthly intravitreal ranibizumab (4-12 injections)
|
|---|---|---|
|
Best Corrected Visual Acuity Area Under the Curve
Visit 2
|
2.50 Letters*day
Standard Deviation 3.7
|
2.82 Letters*day
Standard Deviation 4.4
|
|
Best Corrected Visual Acuity Area Under the Curve
Visit 3
|
4.27 Letters*day
Standard Deviation 5.4
|
4.76 Letters*day
Standard Deviation 6.6
|
|
Best Corrected Visual Acuity Area Under the Curve
Visit 5
|
6.10 Letters*day
Standard Deviation 6.5
|
6.66 Letters*day
Standard Deviation 8.0
|
|
Best Corrected Visual Acuity Area Under the Curve
Visit 6
|
6.65 Letters*day
Standard Deviation 6.7
|
7.50 Letters*day
Standard Deviation 8.3
|
|
Best Corrected Visual Acuity Area Under the Curve
Visit 7
|
7.04 Letters*day
Standard Deviation 6.9
|
8.09 Letters*day
Standard Deviation 8.6
|
|
Best Corrected Visual Acuity Area Under the Curve
Visit 8
|
7.34 Letters*day
Standard Deviation 7.1
|
8.54 Letters*day
Standard Deviation 8.8
|
|
Best Corrected Visual Acuity Area Under the Curve
Visit 9
|
7.60 Letters*day
Standard Deviation 7.2
|
8.92 Letters*day
Standard Deviation 8.9
|
|
Best Corrected Visual Acuity Area Under the Curve
Visit 10
|
7.94 Letters*day
Standard Deviation 7.3
|
9.25 Letters*day
Standard Deviation 9.0
|
|
Best Corrected Visual Acuity Area Under the Curve
Visit 11
|
7.98 Letters*day
Standard Deviation 7.4
|
9.55 Letters*day
Standard Deviation 9.1
|
|
Best Corrected Visual Acuity Area Under the Curve
Visit 12
|
8.17 Letters*day
Standard Deviation 7.4
|
9.82 Letters*day
Standard Deviation 9.2
|
|
Best Corrected Visual Acuity Area Under the Curve
Visit 13
|
8.36 Letters*day
Standard Deviation 7.4
|
10.05 Letters*day
Standard Deviation 9.3
|
|
Best Corrected Visual Acuity Area Under the Curve
Visit 4
|
5.35 Letters*day
Standard Deviation 6.1
|
5.92 Letters*day
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Day 120±3 (Visit 5)Population: The analysis of secondary efficacy variables was conducted in the per-protocol population
Best Corrected Visual Acuity will be evaluated according the standardized ETDRS. The corrected BCVA (adjusted to baseline value) of both treatments will be used evaluated at 4 months. The value was obtained from the value obtained on day 120 minus the baseline value.
Outcome measures
| Measure |
PRO-169
n=186 Participants
Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Bevacizumab: Administration of monthly intravitreal bevacizumab (4-12 injections)
|
Lucentis ®
n=189 Participants
Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Lucentis®: Administration of monthly intravitreal ranibizumab (4-12 injections)
|
|---|---|---|
|
Best Corrected Visual Acuity
|
8.70 Letters
Standard Deviation 8.6
|
9.98 Letters
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit)Population: The analysis of the secondary efficacy variables was conducted in the PP population
Central macular thickness will be evaluated through OCT scan. The mean change between two treatments will be used evaluated as difference between baseline and final (12 months) values.
Outcome measures
| Measure |
PRO-169
n=186 Participants
Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Bevacizumab: Administration of monthly intravitreal bevacizumab (4-12 injections)
|
Lucentis ®
n=189 Participants
Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Lucentis®: Administration of monthly intravitreal ranibizumab (4-12 injections)
|
|---|---|---|
|
Central Macular Thickness
Visit 2
|
-74.43 μm
Standard Deviation 105.1
|
-94.69 μm
Standard Deviation 102.7
|
|
Central Macular Thickness
Visit 3
|
-83.58 μm
Standard Deviation 110.3
|
-115.79 μm
Standard Deviation 100.5
|
|
Central Macular Thickness
Visit 4
|
-96.24 μm
Standard Deviation 112.7
|
-129.63 μm
Standard Deviation 109.6
|
|
Central Macular Thickness
Visit 5
|
-98.12 μm
Standard Deviation 113.0
|
-135.21 μm
Standard Deviation 109.9
|
|
Central Macular Thickness
Visit 6
|
-95.40 μm
Standard Deviation 115.1
|
-140.65 μm
Standard Deviation 115.4
|
|
Central Macular Thickness
Visit 7
|
-97.70 μm
Standard Deviation 117.1
|
-141.84 μm
Standard Deviation 113.0
|
|
Central Macular Thickness
Visit 8
|
-92.59 μm
Standard Deviation 118.9
|
-134.82 μm
Standard Deviation 122.3
|
|
Central Macular Thickness
Visit 9
|
-97.55 μm
Standard Deviation 109.5
|
-139.10 μm
Standard Deviation 113.1
|
|
Central Macular Thickness
Visit 10
|
-106.54 μm
Standard Deviation 115.7
|
-141.55 μm
Standard Deviation 115.1
|
|
Central Macular Thickness
Visit 11
|
-105.67 μm
Standard Deviation 121.5
|
-146.25 μm
Standard Deviation 118.3
|
|
Central Macular Thickness
Visit 12
|
-104.94 μm
Standard Deviation 123.9
|
-147.35 μm
Standard Deviation 123.6
|
|
Central Macular Thickness
Visit 13
|
-102.36 μm
Standard Deviation 129.4
|
-144.10 μm
Standard Deviation 113.0
|
SECONDARY outcome
Timeframe: Day 30±3 (Visit 2), 60±3 (Visit 3), 90±3 (Visit 4), 120±3 (Visit 5), 150±3 (Visit 6), 180±3 (Visit 7), 210±3 (Visit 8), 240±3 (Visit 9), 270±3 (Visit 10), 300±3 (Visit 11), 330±3 (Visit 12), 360±3 (Final Visit)Population: The analysis of the secondary efficacy variables was conducted in the PP population,
Retinal volume will be evaluated through OCT scan. The mean change between two treatments will be used evaluated as difference between baseline and final (12 months) values.
Outcome measures
| Measure |
PRO-169
n=186 Participants
Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Bevacizumab: Administration of monthly intravitreal bevacizumab (4-12 injections)
|
Lucentis ®
n=189 Participants
Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Lucentis®: Administration of monthly intravitreal ranibizumab (4-12 injections)
|
|---|---|---|
|
Retinal Volume
Visit 3
|
-1.00 mm^3
Standard Deviation 1.3
|
-1.26 mm^3
Standard Deviation 1.2
|
|
Retinal Volume
Visit 4
|
-1.12 mm^3
Standard Deviation 1.3
|
-1.57 mm^3
Standard Deviation 1.5
|
|
Retinal Volume
Visit 6
|
-1.32 mm^3
Standard Deviation 1.5
|
-1.77 mm^3
Standard Deviation 1.4
|
|
Retinal Volume
Visit 7
|
-1.32 mm^3
Standard Deviation 1.5
|
-1.82 mm^3
Standard Deviation 1.4
|
|
Retinal Volume
Visit 8
|
-1.34 mm^3
Standard Deviation 1.6
|
-1.72 mm^3
Standard Deviation 1.4
|
|
Retinal Volume
Vist 9
|
-1.40 mm^3
Standard Deviation 1.6
|
-1.79 mm^3
Standard Deviation 1.4
|
|
Retinal Volume
Visit 10
|
-1.46 mm^3
Standard Deviation 1.6
|
-1.84 mm^3
Standard Deviation 1.4
|
|
Retinal Volume
Visit 11
|
-1.51 mm^3
Standard Deviation 1.6
|
-1.93 mm^3
Standard Deviation 1.5
|
|
Retinal Volume
Visit 13
|
-1.49 mm^3
Standard Deviation 1.7
|
-1.87 mm^3
Standard Deviation 1.5
|
|
Retinal Volume
Visit 12
|
-1.60 mm^3
Standard Deviation 1.7
|
-1.88 mm^3
Standard Deviation 1.5
|
|
Retinal Volume
Visit 2
|
-0.84 mm^3
Standard Deviation 1.3
|
-1.06 mm^3
Standard Deviation 1.26
|
|
Retinal Volume
Visit 5
|
-1.23 mm^3
Standard Deviation 1.5
|
-1.67 mm^3
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit)Population: The analysis of secondary efficacy variables was conducted in the per-protocol population (PP).
Determining the percentage of patients with a positive response to treatment, considered as: absolute improvement (20/20 vision for two consecutive visits and central macular thickness \< 300 μm in men and \< 290 μm in women), improvement (one or more of the following: patient who gained 5 or more letters for BCVA, ≥ 10% decrease of macular central thickness value compared to last two visits) and stability (one or more of the following: patient with neither a gain of 5 or more letters for BCVA nor a ≥ 10% decrease of macular central thickness value compared to last two visits, patient without loss of 5 or more letters for BCVA or a ≥ 10% decrease of macular central thickness value compared to last visit).
Outcome measures
| Measure |
PRO-169
n=186 Participants
Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Bevacizumab: Administration of monthly intravitreal bevacizumab (4-12 injections)
|
Lucentis ®
n=189 Participants
Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Lucentis®: Administration of monthly intravitreal ranibizumab (4-12 injections)
|
|---|---|---|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 5 · Improvement
|
88 Participants
|
98 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 5 · Stability
|
65 Participants
|
58 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 5 · Other
|
28 Participants
|
21 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 6 · Absolute improvement
|
6 Participants
|
16 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 6 · Improvement
|
76 Participants
|
80 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 6 · Other
|
38 Participants
|
25 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 7 · Improvement
|
69 Participants
|
69 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 7 · Other
|
41 Participants
|
31 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 8 · Absolute improvement
|
10 Participants
|
18 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 8 · Improvement
|
67 Participants
|
67 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 8 · Stability
|
65 Participants
|
64 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 8 · Other
|
44 Participants
|
40 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 9 · Absolute improvement
|
9 Participants
|
15 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 9 · Improvement
|
75 Participants
|
71 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 9 · Other
|
49 Participants
|
36 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 10 · Other
|
39 Participants
|
35 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 11 · Absolute improvement
|
9 Participants
|
14 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 11 · Stability
|
63 Participants
|
66 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 11 · Other
|
39 Participants
|
30 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 13 · Improvement
|
72 Participants
|
61 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 13 · Stability
|
63 Participants
|
75 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 13 · Other
|
40 Participants
|
36 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 5 · Absolute improvement
|
5 Participants
|
12 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 6 · Stability
|
66 Participants
|
68 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 7 · Absolute improvement
|
8 Participants
|
16 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 7 · Stability
|
68 Participants
|
73 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 9 · Stability
|
53 Participants
|
67 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 10 · Absolute improvement
|
8 Participants
|
14 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 10 · Improvement
|
77 Participants
|
79 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 10 · Stability
|
62 Participants
|
61 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 11 · Improvement
|
75 Participants
|
79 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 12 · Absolute improvement
|
10 Participants
|
20 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 12 · Improvement
|
75 Participants
|
64 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 12 · Stability
|
73 Participants
|
68 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 12 · Other
|
28 Participants
|
37 Participants
|
|
Percentage of Patients With a Positive Response to Treatment.
Visit 13 · Absolute improvement
|
11 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit)Population: The analysis of the secondary efficacy variables was conducted in the PP population,
Determining the mean number of injections applied during study, comparing both arms.
Outcome measures
| Measure |
PRO-169
n=186 Participants
Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Bevacizumab: Administration of monthly intravitreal bevacizumab (4-12 injections)
|
Lucentis ®
n=189 Participants
Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Lucentis®: Administration of monthly intravitreal ranibizumab (4-12 injections)
|
|---|---|---|
|
Mean Number of Injections
|
9.56 injection
Standard Deviation 1.8
|
9.21 injection
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit)Population: The analysis of secondary efficacy variables was conducted in the per-protocol population (PP)
Number of patients who required photocoagulation treatment
Outcome measures
| Measure |
PRO-169
n=186 Participants
Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Bevacizumab: Administration of monthly intravitreal bevacizumab (4-12 injections)
|
Lucentis ®
n=189 Participants
Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Lucentis®: Administration of monthly intravitreal ranibizumab (4-12 injections)
|
|---|---|---|
|
Frequency of Rescue Therapy Administration
|
8 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 360±3 (Final Visit)Population: This result was evaluated in the safety population, which consists of subjects who received at least one dose of the treatment
This section describes the treatment-related adverse events reported throughout the study
Outcome measures
| Measure |
PRO-169
n=255 Participants
Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Bevacizumab: Administration of monthly intravitreal bevacizumab (4-12 injections)
|
Lucentis ®
n=254 Participants
Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Lucentis®: Administration of monthly intravitreal ranibizumab (4-12 injections)
|
|---|---|---|
|
Adverse Events Related to the Injection
|
24 number of events
|
29 number of events
|
SECONDARY outcome
Timeframe: Day 360±3 (Final Visit)Population: This result was evaluated in the safety population, which consists of subjects who received at least one dose of the treatment
The number of adverse events related to the eyes associated with the medication is described.
Outcome measures
| Measure |
PRO-169
n=255 Participants
Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Bevacizumab: Administration of monthly intravitreal bevacizumab (4-12 injections)
|
Lucentis ®
n=254 Participants
Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Lucentis®: Administration of monthly intravitreal ranibizumab (4-12 injections)
|
|---|---|---|
|
Ophthalmic Drug-related Adverse Events
|
9 number of events
|
4 number of events
|
SECONDARY outcome
Timeframe: Day 360±3 (Final Visit)The number of treatment-related adverse events at the systemic level is described
Outcome measures
| Measure |
PRO-169
n=255 Participants
Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Bevacizumab: Administration of monthly intravitreal bevacizumab (4-12 injections)
|
Lucentis ®
n=254 Participants
Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Lucentis®: Administration of monthly intravitreal ranibizumab (4-12 injections)
|
|---|---|---|
|
Systemic Drug-related Adverse Events
|
0 number of events
|
0 number of events
|
Adverse Events
PRO-169
Serious events: 2 serious events
Other events: 114 other events
Deaths: 2 deaths
Lucentis ®
Serious events: 3 serious events
Other events: 103 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
PRO-169
n=255 participants at risk
Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Bevacizumab: Administration of monthly intravitreal bevacizumab (4-12 injections)
|
Lucentis ®
n=254 participants at risk
Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Lucentis®: Administration of monthly intravitreal ranibizumab (4-12 injections)
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Urinary tract infection Septic shock
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Nervous system disorders
Stroke
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Gastrointestinal disorders
Other
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
Other adverse events
| Measure |
PRO-169
n=255 participants at risk
Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Bevacizumab: Administration of monthly intravitreal bevacizumab (4-12 injections)
|
Lucentis ®
n=254 participants at risk
Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Lucentis®: Administration of monthly intravitreal ranibizumab (4-12 injections)
|
|---|---|---|
|
Investigations
High blood pressure
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.79%
2/254 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Investigations
Elevated intraocular pressure
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Cellulitis
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Investigations
Reduced glomerular filtration rate
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Bronchitis
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Investigations
Elevated glycated hemoglobin
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.79%
2/254 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Pregnancy, puerperium and perinatal conditions
miscarriage
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Investigations
Fluctuations in blood glucose levels
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Cystitis
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Conjunctivitis
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.79%
2/254 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Bacterial conjunctivitis
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Viral conjunctivitis
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
COVID-19
|
1.6%
4/255 • Number of events 4 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.79%
2/254 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Dengue
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.79%
2/254 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Pharyngitis
|
1.2%
3/255 • Number of events 3 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
1.2%
3/254 • Number of events 3 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Bacterial pharyngitis
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Viral pharyngitis
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.78%
2/255 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
1.2%
3/254 • Number of events 3 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Gastroenteritis
|
0.78%
2/255 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.79%
2/254 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Ophthalmic herpes
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Bacterial infection of the respiratory tract
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Respiratory tract infection
|
1.2%
3/255 • Number of events 3 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Urinary tract infection
|
2.0%
5/255 • Number of events 5 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
2.4%
6/254 • Number of events 6 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
tooth infection
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Upper respiratory tract viral infection
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Influenza
|
0.78%
2/255 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Nasopharyngitis
|
0.78%
2/255 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Pneumonia
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.79%
2/254 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Onychomycosis
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Sepsis resulting from a wound
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Sepsis
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Suspected COVID-19
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Injury, poisoning and procedural complications
Fall
|
0.78%
2/255 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.79%
2/254 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.79%
2/254 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Injury, poisoning and procedural complications
Bleeding from the vascular access site
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.79%
2/254 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Infections and infestations
Heatstroke
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.79%
2/254 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Injury, poisoning and procedural complications
Thermal burns of the eye
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the vagina
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell endometrial carcinoma
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Surgical and medical procedures
Retinal surgery
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.79%
2/254 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Surgical and medical procedures
Photocoagulation
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Surgical and medical procedures
Vitrectomy
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Cardiac disorders
Angina
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Cardiac disorders
Unstable angina
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Cardiac disorders
Arrhythmia
|
0.78%
2/255 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.79%
2/254 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Cardiac disorders
Heart failure
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.79%
2/254 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Congenital, familial and genetic disorders
Alport syndrome
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
2.0%
5/255 • Number of events 5 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.79%
2/254 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Skin and subcutaneous tissue disorders
Itching at the injection site
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Skin and subcutaneous tissue disorders
Ingrown toenail
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Blood and lymphatic system disorders
Anemia
|
0.78%
2/255 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Metabolism and nutrition disorders
Dyslipidemia
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.79%
2/254 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.78%
2/255 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.2%
3/255 • Number of events 3 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Immune system disorders
Allergy to contrast dye
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Nervous system disorders
Stroke
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
1.2%
3/254 • Number of events 3 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Nervous system disorders
Headache
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
1.6%
4/254 • Number of events 4 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Nervous system disorders
Dizziness
|
0.78%
2/255 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Nervous system disorders
Neuralgia
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Nervous system disorders
Neuritis
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Nervous system disorders
Thoracic outlet syndrome
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Nervous system disorders
Disorder of the nervous system
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Endocrine disorders
Hypoglycemia
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Gastrointestinal disorders
Diarrhea
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
1.2%
3/254 • Number of events 3 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Gastrointestinal disorders
Pain in the upper abdomen
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Gastrointestinal disorders
Constipation
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Gastrointestinal disorders
Hemorrhagic gastritis
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Gastrointestinal disorders
Food poisoning
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Gastrointestinal disorders
Nausea
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
General disorders
Vascular access complication
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
General disorders
Pain at the injection site
|
2.7%
7/255 • Number of events 7 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
2.8%
7/254 • Number of events 7 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
General disorders
Pain at the puncture site
|
1.6%
4/255 • Number of events 4 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.79%
2/254 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
General disorders
Facial swelling
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
General disorders
Peripheral edema
|
2.0%
5/255 • Number of events 5 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.79%
2/254 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
General disorders
Leakage at the infusion site
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
General disorders
Peripheral swelling
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.79%
2/254 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
General disorders
Discomfort at the injection site
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Hepatobiliary disorders
Gallstone
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
1.2%
3/254 • Number of events 3 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Musculoskeletal and connective tissue disorders
Backache
|
0.78%
2/255 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Decreased visual acuity
|
0.78%
2/255 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Macular hole
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Blepharitis
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
1.6%
4/254 • Number of events 4 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Cataract
|
1.2%
3/255 • Number of events 3 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
2.0%
5/254 • Number of events 5 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Floating cells in the vitreous humor
|
1.2%
3/255 • Number of events 3 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Conjunctivochalasis
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Retinal pigment epithelium tear
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Retinal tear
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Retinal detachment
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Detachment of the vitreous body
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Eye pain
|
0.78%
2/255 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Eyelid eczema
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Macular edema
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Glaucoma
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Conjunctival hemorrhage
|
2.4%
6/255 • Number of events 6 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
4.7%
12/254 • Number of events 12 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Vitreous hemorrhage
|
3.1%
8/255 • Number of events 8 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
1.6%
4/254 • Number of events 4 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Conjunctival hyperemia
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Ocular hypertension
|
2.4%
6/255 • Number of events 6 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
1.2%
3/254 • Number of events 3 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Conjunctival irritation
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Eye irritation
|
6.3%
16/255 • Number of events 16 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
7.5%
19/254 • Number of events 19 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Macular ischemia
|
0.78%
2/255 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Eye discomfort
|
2.7%
7/255 • Number of events 7 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
4.7%
12/254 • Number of events 12 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Retinal Artery Occlusion
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Dry eye
|
1.6%
4/255 • Number of events 4 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.79%
2/254 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Parophthalmia
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Itchy eye
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Punctate keratitis
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Eye cyst
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
1.2%
3/254 • Number of events 3 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Vitritis
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Psychiatric disorders
Anxiety
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Psychiatric disorders
Depression
|
0.00%
0/255 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Psychiatric disorders
Anxiety disorder
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Psychiatric disorders
Mental disorder
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Renal and urinary disorders
Urinary stone
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.6%
4/255 • Number of events 4 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.79%
2/254 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Renal and urinary disorders
Hematuria
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Renal and urinary disorders
Kidney failure
|
0.78%
2/255 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.79%
2/254 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Vascular disorders
Hypertensive crisis
|
0.78%
2/255 • Number of events 2 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Vascular disorders
Hypertensive emergency
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Vascular disorders
Peripheral venous disease
|
1.2%
3/255 • Number of events 3 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.39%
1/254 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Vascular disorders
Hypertension
|
1.6%
4/255 • Number of events 4 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
3.5%
9/254 • Number of events 9 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Vascular disorders
Inadequately controlled blood pressure
|
1.2%
3/255 • Number of events 3 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
1.6%
4/254 • Number of events 4 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
|
Vascular disorders
Varicose ulceration
|
0.39%
1/255 • Number of events 1 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
0.00%
0/254 • Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place