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.
≥55 years of age
Willing and able to provide written informed consent
Willing and able to comply with the study schedule and study assessments
Able to successfully administer ophthalmic solution or have an appropriate designee (e.g., family member, health care professional) who can administer ophthalmic solution
Presence or history of choroidal neovascularization (CNV). Criterion will be confirmed at Baseline
History of laser therapy in the macular region, regardless of indication
History of herpes zoster
Ophthalmic disease or condition that requires or is likely to require surgery during the study period
Parallel
GAL-101
DrugPatient will apply daily 2 eye drops of GAL-101 at 5 minutes interval
Placebo
DrugPatient will apply daily 2 eye drops of Placebo at 5 minutes interval
Efficacy of GAL-101 ophthalmic solution in reducing the rate of change in GA lesion size.
Comparison between groups of annual rate of change in the area of GA as measured by fundus autofluorescence (FAF).
Efficacy of GAL-101 ophthalmic solution in reducing the rate of change in photoreceptor degeneration (PRD) in eyes with GA
Comparison between groups of annual rate of change in the area of PRD as measured by optical coherence tomography (OCT)
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