A Phase 3 Registrational Study To Assess The Efficacy, Safety, And Tolerability Of OCU410 For Geographic Atrophy Secondary To Dry Age-Related Macular Degeneration
Ocugen
Summary
This study is a Phase 3 multicenter, randomized, controlled, assessor blinded, adaptive study in which subjects will be randomized in a 2:1(OCU410: control) ratio to treatment arm or control arm
Description
This study is a Phase 3 multicenter, randomized, controlled, assessor blinded, adaptive study in which subjects will be randomized in a 2:1(OCU410: control) ratio to either of the following arms: Treatment arm (OCU410) study subjects will receive single subretinal injection of 200 µL, OCU410 in the study eye with the optimal dose (N=158) Control arm (untreated) (N=79) A total of 237 subjects will be enrolled in the study. Subjects who are enrolled in the untreated control group of the study will not receive any treatment. Subjects randomized to the treatment arm may receive a single subreti…
Eligibility
- Age range
- 55+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subjects 55 years of age or older at consent. 2. BCVA of ≥25 ETDRS letters or more using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (20/320 Snellen Equivalent) and ≤80 ETDRS Letters (20/25 Snellen Equivalent) in the study eye. 3. Fundus autofluorescence (FAF) imaging shows: a)Total GA area ≥2.5 and ≤ 17.5 mm2 (1 to 7 disk areas \[DA\], respectively); b)If GA is multifocal, at least one lesion must be ≥1.25 mm2 (0.5 DA), with the overall aggregate area of GA as specified above in 3a. c)The entire GA lesion must be completely visualized on the macula-centere…
Interventions
- BiologicalOCU410
Subretinal Injection
Location
- Valley Retina InstituteMcAllen, Texas