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RECRUITING
NCT06659549
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

GAL-101

Patient will apply daily 2 eye drops of GAL-101 at 5 minutes interval

DRUG

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