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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
Sponsor: Galimedix Therapeutics Inc
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.
Official title: A Phase 2, Double-masked, Randomized, Multicenter, Parallel Group, Placebo-controlled Study to Investigate the Efficacy and Safety of GAL-101, 2%, Ophthalmic Solution in Patients With Non-foveal Geographic Atrophy Secondary to Non-neovascular Age-related Macular Degeneration: eDREAM Study
Key Details
Gender
All
Age Range
55 Years - Any
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2025-01-10
Completion Date
2027-05-30
Last Updated
2026-02-06
Healthy Volunteers
No
Conditions
Interventions
GAL-101
Patient will apply daily 2 eye drops of GAL-101 at 5 minutes interval
Placebo
Patient will apply daily 2 eye drops of Placebo at 5 minutes interval
Locations (14)
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Ophthalmological Center After S.V. Malayan
Yerevan, Armenia
Centre Monticelli Paradis d'Ophtalmologie
Marseille, France
Akhali Mzera Limited
Tbilisi, Georgia
Caucasus Medical Centre LLC
Tbilisi, Georgia
Chichua Medical Centre Mzera LLC
Tbilisi, Georgia
Universitäts-Augenklinik Bonn
Bonn, Germany
Institute of Eye Surgery (IOES Waterford)
Waterford, Ireland
Hadassah Medical Center
Jerusalem, Israel
Tel Aviv Medical Center
Tel Aviv, Israel
Medical Retina & Imaging Unit, IRCCS MultiMedica, Ospedale San Giuseppe
Milan, Milano, Italy
Unità di Oculistica, IRCCS Ospedale San Raffaele
Milan, Milano, Italy