SGLT2 Inhibitors in Geographic Atrophy

Description

This is a Phase II, prospective, single-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and efficacy of oral dapagliflozin in subjects with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

The study will randomize approximately 70 subjects to obtain at least 60 evaluable subjects at a single center site.

Subjects will be randomized in a 1:1 manner to receive:

1. Dapagliflozin 10 mg (oral) once daily
2. Matching placebo (oral) once daily

Primary outcome of interest will be progression of GA lesion area over the 1-year period measured by fundus autofluorescence (FAF) , and secondary outcomes include structural and functional testing for visual function such as change in drusen volume as measured by OCT, dark adaptation, and low luminance BCVA to determine the effect of dapagliflozin on the progression of dry AMD.

All subjects will return for a final follow-up visit at Month 12, marking the conclusion of the study.