Trial Outcomes & Findings for A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD (NCT NCT03953079)
NCT ID: NCT03953079
Last Updated: 2022-01-19
Results Overview
Kaplan-Meier estimate of the median time to first rescue treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Baseline through 12 months
Results posted on
2022-01-19
Participant Flow
Participant milestones
| Measure |
GB-102 1 mg/1 mg
Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
|
GB-102 2 mg/1 mg
Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
|
Aflibercept 2 mg
Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
|
|---|---|---|---|
|
Core Study
STARTED
|
21
|
22
|
13
|
|
Core Study
COMPLETED
|
20
|
18
|
12
|
|
Core Study
NOT COMPLETED
|
1
|
4
|
1
|
|
Extension Study
STARTED
|
12
|
10
|
6
|
|
Extension Study
COMPLETED
|
6
|
4
|
1
|
|
Extension Study
NOT COMPLETED
|
6
|
6
|
5
|
Reasons for withdrawal
| Measure |
GB-102 1 mg/1 mg
Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
|
GB-102 2 mg/1 mg
Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
|
Aflibercept 2 mg
Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
|
|---|---|---|---|
|
Core Study
Withdrawal by Subject
|
1
|
2
|
1
|
|
Core Study
COVID-19
|
0
|
1
|
0
|
|
Core Study
Difficulties leaving the house
|
0
|
1
|
0
|
|
Extension Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Extension Study
Received Rescue Treatment
|
5
|
6
|
5
|
Baseline Characteristics
A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD
Baseline characteristics by cohort
| Measure |
GB-102 1 mg/1 mg
n=21 Participants
Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
|
GB-102 2 mg/1 mg
n=22 Participants
Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
|
Aflibercept 2 mg
n=13 Participants
Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
54 Participants
n=7 Participants
|
|
Age, Continuous
|
80 years
STANDARD_DEVIATION 8.08 • n=99 Participants
|
77.8 years
STANDARD_DEVIATION 8.58 • n=107 Participants
|
77.5 years
STANDARD_DEVIATION 9.13 • n=206 Participants
|
78.5 years
STANDARD_DEVIATION 8.44 • n=7 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
55 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
54 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
22 participants
n=107 Participants
|
13 participants
n=206 Participants
|
56 participants
n=7 Participants
|
|
Best Corrected Visual Acuity (ETDRS Letters)
|
70.8 ETDRS letters
STANDARD_DEVIATION 11.50 • n=99 Participants
|
70.7 ETDRS letters
STANDARD_DEVIATION 9.92 • n=107 Participants
|
69.6 ETDRS letters
STANDARD_DEVIATION 14.67 • n=206 Participants
|
70.5 ETDRS letters
STANDARD_DEVIATION 11.52 • n=7 Participants
|
|
Central Subfield Thickness
|
211.0 microns
STANDARD_DEVIATION 47.14 • n=99 Participants
|
232.5 microns
STANDARD_DEVIATION 54.37 • n=107 Participants
|
217.5 microns
STANDARD_DEVIATION 31.66 • n=206 Participants
|
221.0 microns
STANDARD_DEVIATION 47.42 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline through 12 monthsKaplan-Meier estimate of the median time to first rescue treatment.
Outcome measures
| Measure |
GB-102 1 mg/1 mg
n=21 Participants
Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
|
GB-102 2 mg/1 mg
n=22 Participants
Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
|
Aflibercept 2 mg
n=13 Participants
Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
|
|---|---|---|---|
|
Time to First Rescue Treatment
|
5 months
Interval 3.0 to 8.0
|
4 months
Interval 3.0 to 4.0
|
NA months
NA = not applicable/ not estimable due to small sample size and insufficient number of participants who needed rescue treatment.
|
SECONDARY outcome
Timeframe: 6 months through 12 monthsPopulation: Full Analysis Set which include all randomized subjects who received at least one dose of study treatment and complete a baseline and at least one post-baseline visit.
Assessment of time to fulfillment of at least one rescue criterion starting at the Month 6 visit through to the Month 12 visit
Outcome measures
| Measure |
GB-102 1 mg/1 mg
n=16 Participants
Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
|
GB-102 2 mg/1 mg
n=14 Participants
Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
|
Aflibercept 2 mg
n=12 Participants
Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
|
|---|---|---|---|
|
Time to Fulfillment of at Least One Rescue Criterion
|
1.5 months
Interval 1.0 to 2.0
|
2 months
NA = not applicable/ not estimable due to small sample size and insufficient number of participants who met rescue criteria.
|
NA months
Interval 6.0 to
NA = not applicable/ not estimable due to small sample size and insufficient number of participants who met rescue criteria.
|
SECONDARY outcome
Timeframe: Baseline through 12 monthsPopulation: The Full Analysis Set (FAS) will include all randomized subjects who receive at least one dose of study treatment, and complete a baseline and at least one post-baseline visit.
Assessment of the number of monthly intervals that at least one rescue criterion is met
Outcome measures
| Measure |
GB-102 1 mg/1 mg
n=21 Participants
Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
|
GB-102 2 mg/1 mg
n=22 Participants
Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
|
Aflibercept 2 mg
n=13 Participants
Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
|
|---|---|---|---|
|
Number of Times That at Least One Rescue Criterion is Met
|
5.1 total monthly interval
Standard Error 3.38
|
6.1 total monthly interval
Standard Error 2.86
|
1.1 total monthly interval
Standard Error 1.26
|
SECONDARY outcome
Timeframe: Baseline through 12 monthsPopulation: The Full Analysis Set (FAS) will include all randomized subjects who receive at least one dose of study treatment, and complete a baseline and at least one post-baseline visit.
Assessment of the number of treatments, including both rescue and scheduled study treatments, that occurred during the study
Outcome measures
| Measure |
GB-102 1 mg/1 mg
n=21 Participants
Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
|
GB-102 2 mg/1 mg
n=22 Participants
Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
|
Aflibercept 2 mg
n=13 Participants
Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
|
|---|---|---|---|
|
Number of Treatments, Including Both Rescue and Scheduled Study Treatments, During the Study
|
4 Injections
Interval 1.0 to 8.0
|
4 Injections
Interval 1.0 to 7.0
|
6 Injections
Interval 3.0 to 7.0
|
SECONDARY outcome
Timeframe: Baseline through 12 monthsPopulation: The Full Analysis Set (FAS) will include all randomized subjects who receive at least one dose of study treatment, and complete a baseline and at least one post-baseline visit.
BCVA = best corrected visual acuity; ETDRS = early treatment of diabetic retinopathy BCVA ETDRS range = 0 (worst) to 100 (best) Assessment of change in BCVA (ETDRS letter score) from baseline at all visits
Outcome measures
| Measure |
GB-102 1 mg/1 mg
n=20 Participants
Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
|
GB-102 2 mg/1 mg
n=18 Participants
Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
|
Aflibercept 2 mg
n=12 Participants
Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
|
|---|---|---|---|
|
Change From Baseline in Best-corrected Visual Acuity (BCVA) (ETDRS Letter Score) at All Visits
|
-7.4 letters
Standard Deviation 4.72
|
-5.1 letters
Standard Deviation 4.37
|
1.8 letters
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Baseline through 12 monthsPopulation: The Full Analysis Set (FAS) will include all randomized subjects who receive at least one dose of study treatment, and complete a baseline and at least one post-baseline visit.
BCVA = best corrected visual acuity; ETDRS = early treatment of diabetic retinopathy BCVA ETDRS range = 0 (worst) to 100 (best) Assessment of categorical change in BCVA (ETDRS letter score) from baseline at all visits
Outcome measures
| Measure |
GB-102 1 mg/1 mg
n=20 Participants
Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
|
GB-102 2 mg/1 mg
n=18 Participants
Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
|
Aflibercept 2 mg
n=12 Participants
Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
|
|---|---|---|---|
|
Categorical Change From Baseline in BCVA (ETDRS Letter Score) at All Visits
>= -9 to <= -5 letters
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Categorical Change From Baseline in BCVA (ETDRS Letter Score) at All Visits
>= -4 to <= 4 letters
|
7 Participants
|
8 Participants
|
5 Participants
|
|
Categorical Change From Baseline in BCVA (ETDRS Letter Score) at All Visits
>= 5 to <= 9 letters
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Categorical Change From Baseline in BCVA (ETDRS Letter Score) at All Visits
>= 10 to <= 14 letters
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Categorical Change From Baseline in BCVA (ETDRS Letter Score) at All Visits
>= 15 letters
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Categorical Change From Baseline in BCVA (ETDRS Letter Score) at All Visits
<= -15 letters
|
7 Participants
|
4 Participants
|
0 Participants
|
|
Categorical Change From Baseline in BCVA (ETDRS Letter Score) at All Visits
>= -14 to <= -10 letters
|
3 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline through 12 monthsPopulation: The Full Analysis Set (FAS) will include all randomized subjects who receive at least one dose of study treatment, and complete a baseline and at least one post-baseline visit.
Assessment of the frequency of subjects with BCVA worse than 20/200 (Snellen equivalent) at all visits A vision score of 20/20 is considered normal. A vision score of 20/200 is considered legally blind.
Outcome measures
| Measure |
GB-102 1 mg/1 mg
n=20 Participants
Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
|
GB-102 2 mg/1 mg
n=18 Participants
Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
|
Aflibercept 2 mg
n=12 Participants
Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
|
|---|---|---|---|
|
Frequency of Subjects With BCVA Worse Than 20/200 (Snellen Equivalent) at All Visits
|
3 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline through 12 monthsPopulation: The Full Analysis Set (FAS) will include all randomized subjects who receive at least one dose of study treatment, and complete a baseline and at least one post-baseline visit.
CST = central subfield thickness Assessment of change in CST (μm) measurement from baseline at all visits
Outcome measures
| Measure |
GB-102 1 mg/1 mg
n=20 Participants
Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
|
GB-102 2 mg/1 mg
n=18 Participants
Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
|
Aflibercept 2 mg
n=12 Participants
Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
|
|---|---|---|---|
|
Change From Baseline in Central Subfield Thickness (CST) (μm) at All Visits
|
41.7 microns
Standard Deviation 20.69
|
27.2 microns
Standard Deviation 11.07
|
7.8 microns
Standard Deviation 15.46
|
SECONDARY outcome
Timeframe: Baseline through 12 monthsPopulation: The Full Analysis Set (FAS) will include all randomized subjects who receive at least one dose of study treatment, and complete a baseline and at least one post-baseline visit.
Assessment of the frequency of subjects with absence of exudation (intra-/sub-retinal fluid/cystoid edema) at all visits
Outcome measures
| Measure |
GB-102 1 mg/1 mg
n=16 Participants
Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
|
GB-102 2 mg/1 mg
n=16 Participants
Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
|
Aflibercept 2 mg
n=9 Participants
Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
|
|---|---|---|---|
|
Frequency of Subjects With Absence of Exudation (Intra-/Sub-retinal Fluid/Cystoid Edema) at at All Visits
|
2 Participants
|
3 Participants
|
1 Participants
|
Adverse Events
GB-102 1 mg/1 mg
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
GB-102 2 mg/1 mg
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Aflibercept 2 mg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GB-102 1 mg/1 mg
n=21 participants at risk
Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
|
GB-102 2 mg/1 mg
n=22 participants at risk
Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
|
Aflibercept 2 mg
n=13 participants at risk
Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
|
|---|---|---|---|
|
Eye disorders
Retinal detachment
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Infections and infestations
Pneumonia
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukemia
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Infections and infestations
Sepsis
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Infections and infestations
Urosepsis
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/21 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
7.7%
1/13 • Number of events 1 • Baseline to Month 18
|
Other adverse events
| Measure |
GB-102 1 mg/1 mg
n=21 participants at risk
Participants receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
|
GB-102 2 mg/1 mg
n=22 participants at risk
Participants receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
|
Aflibercept 2 mg
n=13 participants at risk
Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
|
|---|---|---|---|
|
Eye disorders
Vitreous floaters
|
28.6%
6/21 • Number of events 8 • Baseline to Month 18
|
45.5%
10/22 • Number of events 13 • Baseline to Month 18
|
15.4%
2/13 • Number of events 2 • Baseline to Month 18
|
|
Eye disorders
Iritis
|
23.8%
5/21 • Number of events 6 • Baseline to Month 18
|
45.5%
10/22 • Number of events 11 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Retinal haemorrhage
|
19.0%
4/21 • Number of events 4 • Baseline to Month 18
|
18.2%
4/22 • Number of events 4 • Baseline to Month 18
|
7.7%
1/13 • Number of events 1 • Baseline to Month 18
|
|
Eye disorders
Visual acuity reduced
|
14.3%
3/21 • Number of events 4 • Baseline to Month 18
|
18.2%
4/22 • Number of events 4 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Subretinal fluid
|
9.5%
2/21 • Number of events 2 • Baseline to Month 18
|
9.1%
2/22 • Number of events 2 • Baseline to Month 18
|
7.7%
1/13 • Number of events 1 • Baseline to Month 18
|
|
Eye disorders
Eye pain
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
22.7%
5/22 • Number of events 6 • Baseline to Month 18
|
7.7%
1/13 • Number of events 1 • Baseline to Month 18
|
|
Eye disorders
Cataract
|
9.5%
2/21 • Number of events 4 • Baseline to Month 18
|
13.6%
3/22 • Number of events 3 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Visual impairment
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
9.1%
2/22 • Number of events 3 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Posterior capsule opacification
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
7.7%
1/13 • Number of events 2 • Baseline to Month 18
|
|
Eye disorders
Vitritis
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Subretinal fibrosis
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
7.7%
1/13 • Number of events 1 • Baseline to Month 18
|
|
Eye disorders
Conjunctival hyperaemia
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Retinal oedema
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Retinal thickening
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Uveitis
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Vision blurred
|
9.5%
2/21 • Number of events 2 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Vitreous detachment
|
4.8%
1/21 • Number of events 2 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
7.7%
1/13 • Number of events 2 • Baseline to Month 18
|
|
Eye disorders
Episcleritis
|
0.00%
0/21 • Baseline to Month 18
|
13.6%
3/22 • Number of events 3 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Dry eye
|
0.00%
0/21 • Baseline to Month 18
|
9.1%
2/22 • Number of events 2 • Baseline to Month 18
|
7.7%
1/13 • Number of events 2 • Baseline to Month 18
|
|
Eye disorders
Anterior chamber inflammation
|
0.00%
0/21 • Baseline to Month 18
|
9.1%
2/22 • Number of events 3 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/21 • Baseline to Month 18
|
9.1%
2/22 • Number of events 2 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Corneal oedema
|
0.00%
0/21 • Baseline to Month 18
|
9.1%
2/22 • Number of events 3 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Keratic precipitates
|
0.00%
0/21 • Baseline to Month 18
|
9.1%
2/22 • Number of events 4 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Photophobia
|
0.00%
0/21 • Baseline to Month 18
|
9.1%
2/22 • Number of events 3 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Choroidal neovascularisation
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Dermatochalasis
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Eye allergy
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Iris adhesions
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Papilloedema
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Scleritis
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Vitreous degeneration
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Neovascular age-related macular degeneration
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
15.4%
2/13 • Number of events 3 • Baseline to Month 18
|
|
Eye disorders
Subretinal hyperreflective exudation
|
0.00%
0/21 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
7.7%
1/13 • Number of events 1 • Baseline to Month 18
|
|
Investigations
Product residue present
|
19.0%
4/21 • Number of events 4 • Baseline to Month 18
|
27.3%
6/22 • Number of events 7 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Investigations
Intraocular pressure increased
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
4.5%
1/22 • Number of events 4 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Investigations
Optical coherence tomography abnormal
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Infections and infestations
Conjunctivitis
|
9.5%
2/21 • Number of events 2 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Infections and infestations
Hordeolum
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
7.7%
1/13 • Number of events 1 • Baseline to Month 18
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
3/21 • Number of events 3 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
15.4%
2/13 • Number of events 2 • Baseline to Month 18
|
|
Infections and infestations
Sinusitis
|
0.00%
0/21 • Baseline to Month 18
|
13.6%
3/22 • Number of events 3 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Infections and infestations
Urinary tract infection
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
7.7%
1/13 • Number of events 1 • Baseline to Month 18
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Infections and infestations
Pneumonia
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Infections and infestations
Cystitis
|
0.00%
0/21 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
7.7%
1/13 • Number of events 1 • Baseline to Month 18
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/21 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
7.7%
1/13 • Number of events 1 • Baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
2/21 • Number of events 2 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21 • Number of events 2 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
7.7%
1/13 • Number of events 2 • Baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
9.1%
2/22 • Number of events 2 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/21 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
7.7%
1/13 • Number of events 1 • Baseline to Month 18
|
|
Nervous system disorders
Dementia
|
9.5%
2/21 • Number of events 2 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Nervous system disorders
Sinus headache
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Nervous system disorders
Headache
|
0.00%
0/21 • Baseline to Month 18
|
13.6%
3/22 • Number of events 3 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Nervous system disorders
Syncope
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Injury, poisoning and procedural complications
Muscle strain
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/21 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
7.7%
1/13 • Number of events 1 • Baseline to Month 18
|
|
Psychiatric disorders
Insomnia
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Psychiatric disorders
Delirium
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Renal and urinary disorders
Nephrolithiasis
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Ear and labyrinth disorders
Vertigo
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Vascular disorders
Hypertension
|
0.00%
0/21 • Baseline to Month 18
|
9.1%
2/22 • Number of events 2 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Gastrointestinal disorders
Loose tooth
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
General disorders
Localised oedema
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Investigations
Blood pressure increased
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Infections and infestations
Gastroenteritis viral
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Infections and infestations
Herpes zoster
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Gastrointestinal disorders
Constipation
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Cardiac disorders
Atrioventricular block second degree
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
General disorders
Hypothermia
|
4.8%
1/21 • Number of events 1 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal wall neoplasm malignant
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/21 • Baseline to Month 18
|
0.00%
0/22 • Baseline to Month 18
|
7.7%
1/13 • Number of events 1 • Baseline to Month 18
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Lens discolouration
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
|
Eye disorders
Dry age-related macular degeneration
|
0.00%
0/21 • Baseline to Month 18
|
4.5%
1/22 • Number of events 1 • Baseline to Month 18
|
0.00%
0/13 • Baseline to Month 18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any investigator wishing to publish or present any study finding must present a manuscript or abstract to Graybug Vision 120 days prior to submission for publication or presentation to provide Graybug Vision an opportunity for review and comment.
- Publication restrictions are in place
Restriction type: OTHER