A Phase 2 Study to Investigate the Safety and Effectiveness of GAL-101 Eye Drops in Patients With Non-foveal Geographic Atrophy Due to Non-neovascular Age-related Macular Degeneration

What this Trial Is About

Age-related macular degeneration (AMD) affects many older adults, leading to a condition called Geographic Atrophy (GA) where parts of the retina lose light-sensitive cells and vision is impaired. This trial evaluates whether the eyedrop medication GAL-101 can slow the growth of GA and prevent it from damaging central vision. The study is a Phase 2, randomized, placebo-controlled trial where neither patients nor doctors know who receives the active treatment or placebo. Participants will be randomly assigned to receive either GAL-101 eyedrops or placebo drops. During clinic visits, patients will apply three drops at 5-minute intervals under supervision, and outside visits, they will administer two drops once daily. The treatment period will last between 12 and 24 months, with regular visits for safety and effectiveness assessments including an initial screening, baseline visit, phone check at 2 weeks, and follow-up visits at 1, 3, 6, 9, and 12 months, continuing every 3 months thereafter until the last patient completes 12 months. Throughout the study, participants will undergo imaging and vision tests to monitor the size of GA lesions and photoreceptor degeneration. The main outcome is the change in GA lesion size from the start to the end of treatment. Safety evaluations and adherence to the eyedrop schedule will be closely monitored. The total participation duration may be up to 24 months, with ongoing assessments to understand the treatment's impact on vision preservation.

A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD