Trial Outcomes & Findings for A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Diabetic Macular Edema and Retinal Vein Occlusion (NCT NCT04085341)
NCT ID: NCT04085341
Last Updated: 2021-11-22
Results Overview
Number of subjects with an adverse event across all study visits
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Baseline through Month 6
Results posted on
2021-11-22
Participant Flow
Participant milestones
| Measure |
GB-102 Dose 1 (1 mg)
Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.
GB-102: Intravitreal injection of GB-102
|
GB-102 Dose 2 (2 mg)
Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.
GB-102: Intravitreal injection of GB-102
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Diabetic Macular Edema and Retinal Vein Occlusion
Baseline characteristics by cohort
| Measure |
GB-102 Dose 1 (1 mg)
n=10 Participants
Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.
GB-102: Intravitreal injection of GB-102
|
GB-102 Dose 2 (2 mg)
n=11 Participants
Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.
GB-102: Intravitreal injection of GB-102
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 13.83 • n=93 Participants
|
65.1 years
STANDARD_DEVIATION 10.5 • n=4 Participants
|
64.9 years
STANDARD_DEVIATION 11.88 • n=27 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
11 participants
n=4 Participants
|
21 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline through Month 6Number of subjects with an adverse event across all study visits
Outcome measures
| Measure |
GB-102 Dose 1 (1 mg)
n=10 Participants
Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.
GB-102: Intravitreal injection of GB-102
|
GB-102 Dose 2 (2 mg)
n=11 Participants
Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.
GB-102: Intravitreal injection of GB-102
|
|---|---|---|
|
Occurrence of Adverse Events (AEs) Across All Study Visits
|
7 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 6BCVA = best corrected visual acuity; ETDRS = early treatment of diabetic retinopathy BCVA = 0 (worst) to 100 (best) Assessment of change in BCVA (ETDRS letter score) from baseline at all visits
Outcome measures
| Measure |
GB-102 Dose 1 (1 mg)
n=10 Participants
Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.
GB-102: Intravitreal injection of GB-102
|
GB-102 Dose 2 (2 mg)
n=11 Participants
Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.
GB-102: Intravitreal injection of GB-102
|
|---|---|---|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) (ETDRS) at All Study Visits
|
-10.4 letters
Interval -32.0 to 4.0
|
-16.7 letters
Interval -75.0 to 15.0
|
SECONDARY outcome
Timeframe: Baseline to Month 6CST = central subfield thickness SD-OCT = spectral domain-optical coherence tomography Assessment of change in CST (μm) measurement from baseline at all visits
Outcome measures
| Measure |
GB-102 Dose 1 (1 mg)
n=10 Participants
Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.
GB-102: Intravitreal injection of GB-102
|
GB-102 Dose 2 (2 mg)
n=10 Participants
Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.
GB-102: Intravitreal injection of GB-102
|
|---|---|---|
|
Mean Change From Baseline in Central Subfield Thickness (CST) (SD-OCT) at All Study Visits
|
131.0 micrometers
Interval -13.0 to 374.0
|
-37.4 micrometers
Interval -198.0 to 73.0
|
SECONDARY outcome
Timeframe: Baseline through Month 6Assessment of time to rescue treatment over 6 months of treatment
Outcome measures
| Measure |
GB-102 Dose 1 (1 mg)
n=10 Participants
Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.
GB-102: Intravitreal injection of GB-102
|
GB-102 Dose 2 (2 mg)
n=11 Participants
Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.
GB-102: Intravitreal injection of GB-102
|
|---|---|---|
|
Time to Rescue Treatment
|
90 days
Interval 60.0 to 120.0
|
120 days
Interval 60.0 to
NA = not applicable/ not estimable due to small sample size and insufficient number of participants who needed rescue treatment.
|
Adverse Events
GB-102 Dose 1 (1 mg)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
GB-102 Dose 2 (2 mg)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GB-102 Dose 1 (1 mg)
n=10 participants at risk
Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.
GB-102: Intravitreal injection of GB-102
|
GB-102 Dose 2 (2 mg)
n=11 participants at risk
Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.
GB-102: Intravitreal injection of GB-102
|
|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
10.0%
1/10 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
0.00%
0/11 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 2 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Corneal Oedema
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Visual Impairment
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
Other adverse events
| Measure |
GB-102 Dose 1 (1 mg)
n=10 participants at risk
Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.
GB-102: Intravitreal injection of GB-102
|
GB-102 Dose 2 (2 mg)
n=11 participants at risk
Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.
GB-102: Intravitreal injection of GB-102
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Gastrointestinal disorders
Gastrointestinal Vascular Malformation Haemorrhagic
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Investigations
Blood Potassium Decreased
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Blepharitis
|
10.0%
1/10 • Number of events 2 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
0.00%
0/11 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Cataract
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 2 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Posterior Capsule Opacification
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 2 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Retinal Aneurysm
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Eye Pain
|
20.0%
2/10 • Number of events 2 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
27.3%
3/11 • Number of events 3 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Visual Acuity Reduced
|
20.0%
2/10 • Number of events 2 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
27.3%
3/11 • Number of events 3 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Vitreous Floaters
|
20.0%
2/10 • Number of events 2 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
27.3%
3/11 • Number of events 3 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Macular Edema
|
40.0%
4/10 • Number of events 4 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
0.00%
0/11 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Vision Blurred
|
20.0%
2/10 • Number of events 2 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Visual Impairment
|
10.0%
1/10 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 2 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
18.2%
2/11 • Number of events 2 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Swelling of Eyelid
|
10.0%
1/10 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Cataract Nuclear
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Conjunctival Irritation
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Corneal Edema
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Eye Irritation
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Eye Edema
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Iritis
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Ocular Hyperaemia
|
10.0%
1/10 • Number of events 2 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
0.00%
0/11 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Pterygium
|
10.0%
1/10 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
0.00%
0/11 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Punctate Keratitis
|
10.0%
1/10 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
0.00%
0/11 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Eye disorders
Pupils Unequal
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Investigations
Product Residue Present
|
20.0%
2/10 • Number of events 2 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
54.5%
6/11 • Number of events 8 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Investigations
Intraocular Pressure Increased
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
18.2%
2/11 • Number of events 4 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Investigations
Vital Dye Staining Cornea Present
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Infections and infestations
Chorioretinitis
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/10 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
9.1%
1/11 • Number of events 1 • Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Ocular AEs are presented for both study eye and non-study eye combined.
|
Additional Information
Director, Global Clinical Development Operations
Graybug Vision
Phone: 5622098872
Email: [email protected]
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