A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic A… (NCT06659549) | Clinical Trial Compass
RecruitingPhase 2
A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD
United States, Armenia, France110 participantsStarted 2025-01-10
Plain-language summary
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.
Who can participate
Age range55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Well-delineated cumulative GA area between 1.25 and 12.0 mm2
✓. If GA is multifocal, at least 1 lesion ≥1.25 mm2
✓. GA lesions must be located outside a ≥100 µm radius from the center point of the fovea (i.e., this area must have intact retinal pigment epithelium \[RPE\] and outer retina)
✓. GA lesions must be located (partially or wholly) within a 2000 µm radius from the center point of the fovea
✓. GA lesions must be completely located within FAF imaging field (field 2 to 30-degree image centered on the fovea). GA lesion borders must be \>300 µm from image edges
✓. GA lesions must be \>300 µm from the optic disc and/or peripapillary atrophy
✓. Area of PRD must be cumulatively between 7.25 and 25.0 mm2
Exclusion criteria
✕. Presence or history of choroidal neovascularization (CNV). Criterion will be confirmed at Baseline
✕. History of laser therapy in the macular region, regardless of indication
What they're measuring
1
Efficacy of GAL-101 ophthalmic solution in reducing the rate of change in GA lesion size.
Timeframe: From baseline to last on-treatment visit (48 up to 96 weeks)
✕. Ophthalmic disease or condition that requires or is likely to require surgery during the study period
✕. GA with cumulative area \<1.25 mm2
✕. Any GA lesion within 100 µm radius from the center point of the fovea
✕. Axial length \>26 mm
✕. Any ocular disease or condition other than non-neovascular AMD that may, in the opinion of the Investigator, interfere with study assessments, patient adherence to the study schedule, or interpretation of study data (e.g., epiretinal membrane, macular hole, glaucomatous optic neuropathy, etc.)