Trial Outcomes & Findings for Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy (NCT NCT01469156)
NCT ID: NCT01469156
Last Updated: 2022-12-12
Results Overview
Examples include 30 letter loss, major subretinal hemorrhage, involving 75% or more clinical macula (arcade to arcade), disease related vitreous hemorrhage, injection-related endophthalmitis, retinal detachment, vitreous hemorrhage, study drug/procedure - related uveitis, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
2 years
Results posted on
2022-12-12
Participant Flow
Participant milestones
| Measure |
Ranibizumab 1.0 or 2.0 mg (HIGH DOSE)
Intraocular injection of 2.0 mg/0.05 cc ranibizumab or 1.0mg/0.05cc ranibizumab.
Photodynamic therapy with visudyne or laser photocoagulation or intravitreal steroids may be considered as monotherapy or in combination with Ranibizumab at the investigator's discretion if rescue criteria are met
ranibizumab 0.5 or 2.0 mg/0.05 cc: ranibizumab (3:1 ratio of 2mg:0.5 mg ranibizumab) administered in three initial monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month off drug safety follow up.
|
Ranibizumab 0.5 mg
Intraocular injection of 0.5 mg/0.05 cc ranibizumab.
Photodynamic therapy with visudyne or laser photocoagulation or intravitreal steroids may be considered as monotherapy or in combination with Ranibizumab at the investigator's discretion if rescue criteria are met
ranibizumab 0.5 or 2.0 mg/0.05 cc: ranibizumab (3:1 ratio of 2mg:0.5 mg ranibizumab) administered in three initial monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month off drug safety follow up.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
5
|
|
Overall Study
COMPLETED
|
15
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy
Baseline characteristics by cohort
| Measure |
Ranibizumab 1.0 or 2.0 mg (HIGH DOSE)
n=15 Participants
Intraocular injection of 2.0 mg/0.05 cc ranibizumab.
Photodynamic therapy with visudyne or laser photocoagulation or intravitreal steroids may be considered as monotherapy or in combination with Ranibizumab at the investigator's discretion if rescue criteria are met
ranibizumab 0.5 or 2.0 mg/0.05 cc: ranibizumab (3:1 ratio of 2mg:0.5 mg ranibizumab) administered in three initial monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month off drug safety follow up.
|
Ranibizumab 0.5 mg
n=5 Participants
Intraocular injection of 0.5 mg/0.05 cc ranibizumab.
Photodynamic therapy with visudyne or laser photocoagulation or intravitreal steroids may be considered as monotherapy or in combination with Ranibizumab at the investigator's discretion if rescue criteria are met
ranibizumab 0.5 or 2.0 mg/0.05 cc: ranibizumab (3:1 ratio of 2mg:0.5 mg ranibizumab) administered in three initial monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month off drug safety follow up.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsExamples include 30 letter loss, major subretinal hemorrhage, involving 75% or more clinical macula (arcade to arcade), disease related vitreous hemorrhage, injection-related endophthalmitis, retinal detachment, vitreous hemorrhage, study drug/procedure - related uveitis, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs.
Outcome measures
| Measure |
Control Group: Ranibizumab 0.5mg
n=5 Participants
standard-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
Ranibizumab 1.0mg or 2.0mg
n=15 Participants
high-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
|---|---|---|
|
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.
Total Ocular and Notable Systemic AEs
|
4 Adverse events
|
24 Adverse events
|
|
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.
Blurred or decreased vision
|
0 Adverse events
|
6 Adverse events
|
|
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.
Dark Spots
|
0 Adverse events
|
3 Adverse events
|
|
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.
Superior hemorrhage
|
0 Adverse events
|
1 Adverse events
|
|
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.
Increased Choroidal Neovascularization
|
0 Adverse events
|
1 Adverse events
|
|
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.
Progression of edema
|
0 Adverse events
|
1 Adverse events
|
|
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.
Floaters
|
2 Adverse events
|
4 Adverse events
|
|
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.
Injection site or ocular pain
|
0 Adverse events
|
2 Adverse events
|
|
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.
Increased Cataracts
|
0 Adverse events
|
2 Adverse events
|
|
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.
Subretinal hemorrhage
|
0 Adverse events
|
1 Adverse events
|
|
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.
Corneal abrasion
|
0 Adverse events
|
1 Adverse events
|
|
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.
Trace epiretinal membrane
|
0 Adverse events
|
1 Adverse events
|
|
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.
Flashes
|
0 Adverse events
|
1 Adverse events
|
|
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.
Light sensitivity
|
1 Adverse events
|
0 Adverse events
|
|
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.
Elevated blood pressure
|
1 Adverse events
|
0 Adverse events
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Randomized in a 3:1 ratio - number in participant flow is 20
Outcome measures
| Measure |
Control Group: Ranibizumab 0.5mg
n=15 Participants
standard-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
Ranibizumab 1.0mg or 2.0mg
n=5 Participants
high-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
|---|---|---|
|
Mean Best Corrected Visual Acuity Letter Change at 4 Meters Between Baseline and 12 Months
|
6.7 letters
Interval -3.0 to 25.0
|
-5 letters
Interval -25.0 to 9.0
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Randomized in a 3:1 ratio
Outcome measures
| Measure |
Control Group: Ranibizumab 0.5mg
n=15 Participants
standard-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
Ranibizumab 1.0mg or 2.0mg
n=5 Participants
high-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
|---|---|---|
|
Change in Mean Central Foveal Thickness From Baseline
|
-49.7 um
Standard Deviation 100.71
|
94.4 um
Standard Deviation 89.6
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Randomized in a 3:1 ratio
Outcome measures
| Measure |
Control Group: Ranibizumab 0.5mg
n=15 Participants
standard-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
Ranibizumab 1.0mg or 2.0mg
n=5 Participants
high-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
|---|---|---|
|
Mean Change From Baseline in Total Area of FA CNV Leakage Over 12 Months
|
2.38 mm^2
Interval -1.12 to 8.71
|
-0.38 mm^2
Interval -1.12 to -0.02
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: Randomized in a 3:1 ratio - number in participant flow is 20
Outcome measures
| Measure |
Control Group: Ranibizumab 0.5mg
n=15 Participants
standard-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
Ranibizumab 1.0mg or 2.0mg
n=5 Participants
high-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
|---|---|---|
|
Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
5-9 letters
|
3 Participants
|
0 Participants
|
|
Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
10-14 letters
|
2 Participants
|
0 Participants
|
|
Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
15 letters or more
|
3 Participants
|
0 Participants
|
|
Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
Less than 5 letters
|
6 Participants
|
0 Participants
|
|
Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
Unevaluable
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Randomized in a 3:1 ratio - number in participant flow is 20
Outcome measures
| Measure |
Control Group: Ranibizumab 0.5mg
n=15 Participants
standard-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
Ranibizumab 1.0mg or 2.0mg
n=5 Participants
high-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
|---|---|---|
|
Number of Participants at Month 6 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
5 letters
|
3 Participants
|
1 Participants
|
|
Number of Participants at Month 6 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
10 letters
|
1 Participants
|
0 Participants
|
|
Number of Participants at Month 6 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
15 or more letters
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 9 MonthsPopulation: Randomized in a 3:1 ratio - number in participant flow is 20
Outcome measures
| Measure |
Control Group: Ranibizumab 0.5mg
n=15 Participants
standard-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
Ranibizumab 1.0mg or 2.0mg
n=5 Participants
high-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
|---|---|---|
|
Number of Participants at Month 9 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
5 letters
|
3 Participants
|
0 Participants
|
|
Number of Participants at Month 9 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
10 letters
|
3 Participants
|
0 Participants
|
|
Number of Participants at Month 9 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
15 letters
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Randomized in a 3:1 ratio - number in participant flow is 20
Outcome measures
| Measure |
Control Group: Ranibizumab 0.5mg
n=15 Participants
standard-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
Ranibizumab 1.0mg or 2.0mg
n=5 Participants
high-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
|---|---|---|
|
Number of Participants at Month 12 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
5 letters
|
4 Participants
|
1 Participants
|
|
Number of Participants at Month 12 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
10 letters
|
1 Participants
|
0 Participants
|
|
Number of Participants at Month 12 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
15 letters
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Randomized in a 3:1 ratio - number in participant flow is 20
Outcome measures
| Measure |
Control Group: Ranibizumab 0.5mg
n=15 Participants
standard-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
Ranibizumab 1.0mg or 2.0mg
n=5 Participants
high-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
|---|---|---|
|
Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12
Mean Change Baseline - M3
|
9.87 letters
Standard Deviation 15.27
|
-2.8 letters
Standard Deviation 32.71
|
|
Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12
Mean Change Baseline - M6
|
10.23 letters
Standard Deviation 33.51
|
-3.6 letters
Standard Deviation 2.35
|
|
Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12
Mean Change Baseline - M9
|
10.93 letters
Standard Deviation 43.81
|
-6.8 letters
Standard Deviation 9.08
|
|
Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12
Mean Change Baseline - M12
|
6.37 letters
Standard Deviation 26.02
|
-7.3 letters
Standard Deviation 20.11
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Randomized in a 3:1 ratio - number in participant flow is 20
Outcome measures
| Measure |
Control Group: Ranibizumab 0.5mg
n=15 Participants
standard-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
Ranibizumab 1.0mg or 2.0mg
n=5 Participants
high-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
|---|---|---|
|
Number of Participants at Month 3 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
5 letters
|
1 Participants
|
0 Participants
|
|
Number of Participants at Month 3 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
10 letters
|
0 Participants
|
0 Participants
|
|
Number of Participants at Month 3 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
15 letters
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Randomized in a 3:1 ratio - number in participant flow is 20
Outcome measures
| Measure |
Control Group: Ranibizumab 0.5mg
n=15 Participants
standard-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
Ranibizumab 1.0mg or 2.0mg
n=5 Participants
high-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
|---|---|---|
|
Number of Participants at Month 6 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
15 letters
|
1 Participants
|
0 Participants
|
|
Number of Participants at Month 6 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
5 letters
|
0 Participants
|
1 Participants
|
|
Number of Participants at Month 6 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
10 letters
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Randomized in a 3:1 ratio - number in participant flow is 20
Outcome measures
| Measure |
Control Group: Ranibizumab 0.5mg
n=15 Participants
standard-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
Ranibizumab 1.0mg or 2.0mg
n=5 Participants
high-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
|---|---|---|
|
Number of Participants at Month 9 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
5 letters
|
0 Participants
|
0 Participants
|
|
Number of Participants at Month 9 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
10 letters
|
0 Participants
|
0 Participants
|
|
Number of Participants at Month 9 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
15 letters
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Randomized in a 3:1 ratio - number in participant flow is 20
Outcome measures
| Measure |
Control Group: Ranibizumab 0.5mg
n=15 Participants
standard-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
Ranibizumab 1.0mg or 2.0mg
n=5 Participants
high-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
|---|---|---|
|
Number of Participants at Month 12 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
5 letters
|
0 Participants
|
1 Participants
|
|
Number of Participants at Month 12 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
10 letters
|
0 Participants
|
0 Participants
|
|
Number of Participants at Month 12 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
15 letters
|
0 Participants
|
1 Participants
|
Adverse Events
Control Group: Ranibizumab 0.5mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Ranibizumab 1.0mg or 2.0mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Group: Ranibizumab 0.5mg
n=5 participants at risk
standard-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
Ranibizumab 1.0mg or 2.0mg
n=15 participants at risk
high-dose ranibizumab in 3 monthly loading doses, followed by 9 months of criteria-based, as-needed retreatment
|
|---|---|---|
|
Eye disorders
Affected vision
|
20.0%
1/5 • Number of events 3
|
40.0%
6/15 • Number of events 14
|
|
Eye disorders
Intravitreal injection side effects
|
0.00%
0/5
|
13.3%
2/15 • Number of events 3
|
|
Eye disorders
Increased cataract
|
0.00%
0/5
|
13.3%
2/15 • Number of events 2
|
|
Eye disorders
Superior hemorrhage
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Eye disorders
Increased Choroidal neovascularization
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Eye disorders
Corneal Abrasion
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Eye disorders
Trace epiretinal membrane
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
Progression of edema
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
Elevated Blood pressure
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place