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

Study acronym: eDREAM
StatusRecruiting
PhasePhase 2
Started2025-01-10
View on ClinicalTrials.gov ↗
Age-related macular degeneration (AMD) affects millions of elderly patients. When advanced, there is Geographic Atrophy (GA) in the retina. This means that there is an area with a loss of light-sensitive cells, called photoreceptors. That part of the retina can no longer see. Atrophy begins as a small spot in the retina distant from the fovea which is the part of the retina responsible for sharp central vision. The GA grows, and when it reaches the fovea, vision is severely diminished, and details cannot be seen anymore. The purpose of the eDREAM study is to understand if GAL-101 can slow the growth of GA and prevent it from reaching the fovea. GAL-101 is given as eyedrops. eDREAM patients will administer study eyedrops every day. Patients will be assigned by chance (randomly) to receive either eye-drops that contain the new medication, GAL-101, or eyedrops without the active drug (Placebo). Neither patients nor doctors will know which treatment was assigned to each patient until the end of the study.

Amendment history 2 changes detected by DataLookout

2026-08-15
minor
Trial sites expanded: 20 → 25 locations
2026-08-07
minor
Trial sites expanded: 14 → 20 locations
Trial Details
NCT Number NCT06659549
Lead Sponsor Galimedix Therapeutics Inc
Conditions Geographic Atrophy of the Macula
Enrollment 110 participants
Start Date 2025-01-10
Primary Completion 2027-03-30 (estimated)
Study Completion 2027-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-20