A Phase 2, Randomized, Masked, Placebo-Controlled Study of Subcutaneously Administered ADX-038 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Condition studied

Geographic atrophy secondary to age-related macular degeneration

Investigational medicinal product(s)

Eligibility

Primary endpoint

Slope of change in GA area (square root transformation) as measured by FAF from baseline to Month 12 (expressed in mm/year) in the study eye

Endpoint detail

Slope of change in GA area (square root transformation) as measured by FAF from baseline to Month 24 (expressed in mm/year) in the study eye; Rate of change in the macular area of photoreceptor loss (defined as an EZ-RPE thickness of 0 μm) assessed by OCT and EZ mapping at Month 12 and Month 24, Proportion of participants with ≥15 letter loss in ETDRS letters in the study eye at 2 consecutive visits or EOS Visit