Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy (ArMaDa)
Geographic Atrophy
About this trial
This is an interventional treatment trial for Geographic Atrophy
Eligibility Criteria
Inclusion Criteria: Subjects 50 years of age or older. BCVA of approximately 24 letters or more using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (20/320 Snellen equivalent). Fundus autofluorescence (FAF) imaging shows: Total GA area ≥2.5 and ≤17.5 mm2 (1 and 7 disk areas [DA], respectively) If GA is multifocal, at least one focal lesion must be ≥1.25 mm2 (0.5 DA), with the overall aggregate area of GA The entire GA lesion must be completely visualized on the macula-centered image and must be able to be imaged in its entirety, and not contiguous with any areas of peripapillary atrophy Absence of any pattern of hyper-autofluorescence in the junctional zone of GA Exclusion Criteria: Previous treatment with a gene-therapy or cell therapy product Previous treatment with any investigational drug or device within one year. The history of any investigational product with a washout period of up to six months will be evaluated on a case-by-case basis. Previous treatment with Syfovre (Pegcetacoplan injection) GA due to causes other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like Plaquenil maculopathy. however, benign conditions of the vitreous or peripheral retina are not exclusionary (i.e., pavingstone degeneration).
Sites / Locations
- Retina Consultants of TexasRecruiting
- Retina Foundation of the SouthwestRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
No Intervention
Phase1 Dose Escalation- Low Dose (2.5×10E10 vg/mL):
Phase1 Dose Escalation- Medium Dose (5×10E10 vg/mL):
Phase1 Dose Escalation- High Dose (1.5×10E11 vg/mL):
Phase 2 Dose Expansion: Maximum tolerated dose (MTD) from Phase 1-Randomized Arm
Phase 2 Dose Expansion: Lower Dose from Phase 1-Randomized Arm
Control Arm
Low Dose (2.5×10E10 vg/mL): Subjects will receive a subretinal injection of OCU410 in the low dose concentration.
Medium Dose (5×10E10 vg/mL): Subjects will receive a subretinal injection of OCU410 in the medium dose concentration.
High Dose (1.5×10E11 vg/mL): Subjects will receive a subretinal injection in the high dose concentration.
Maximum tolerated dose (MTD) from Phase 1: Subjects will receive a subretinal injection in the MTD concentration.
Subjects will receive a subretinal injection of OCU410 in a Lower Dose concentration.
No Intervention Control Arm: Subject will not receive any active study intervention