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
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 subretinal injection of OCU410 in the study eye, provided they meet all treatment eligibility criteria. Subjects who are randomized to the control arm will not receive any intervention during the initial 52 weeks (12 Months) of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
237
Subretinal Injection
associated Retina Consultants
Phoenix, Arizona, United States
NOT_YET_RECRUITINGErie Retina Research
Erie, Pennsylvania, United States
NOT_YET_RECRUITINGValley Retina Institute
McAllen, Texas, United States
RECRUITINGRate of change (slope) of square root-transformed GA lesion area from baseline to Month 12
Rate of change (slope) of square root-transformed GA lesion area (√mm²/year) from baseline to Month 12 in treated eyes compared to control eyes as assessed by fundus autofluorescence (FAF) measurements
Time frame: Month 12
Proportion of subjects experiencing a low-luminance visual acuity (LLVA) ≥15 Letter Loss from Baseline to M12
Proportion of subjects experiencing a low-luminance visual acuity (LLVA) ≥15 Letter Loss from Baseline to M12 as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) visual charts
Time frame: Month 12
Rate of change of ellipsoid zone (EZ) area loss at Month 12
Rate of change of ellipsoid zone (EZ) area loss over Month 12 as assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT)
Time frame: Month 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.