A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD
Start Date
1/10/2025
Completion Date
5/30/2027
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.
Detailed Description
In this study, if both eyes qualify for the study, the eye with the better BCVA will be defined as the study eye. If both eyes qualify for the study and have identical BCVA, then the eye with higher baseline peripheral retinal degenerations (PRD) will be defined as the study eye. If baseline PRD is identical, then the right eye (OD) will be defined as the study eye. Only the study eye will be dosed with the Investigation Medicinal Product (IMP). During visits, patients will administer 3 applications of 1 drop of GAL-101 or a matching Placebo that does not contain the active pharmaceutical ingredient (API) at 5-minute intervals (i.e., 1st application, wait 5 minutes, 2nd application, wait 5 minutes, 3rd application), under the supervision of trained and authorized study personnel. In between visits, patients will be instructed to administer 2 applications of 1 drop at 5-minute intervals once a day. The study will be comprised of a 12- to 24-month treatment period determined individually according to patients' overall placement in global study randomization. All patients will participate at least 12 months of treatment. The visit schedule includes the following: Screening visits (Visit 1a and 1b) for image capture and confirmation of study eligibility by a reading center; Baseline/Randomization/Day 1 (Visit 2); a phone call at 2 weeks; and on-treatment clinic visits for safety and efficacy evaluations at 1 month, 3 months, 6 months, 9 months, and 12 months. Patients will continue to attend on-treatment clinic visits at 3-month intervals after 12 months until the last patient randomized in the study has completed 12 months of study treatment.
Eligibility Criteria
Age Range: 55 years to No maximum
Interventions
GAL-101
Placebo
Conditions
Locations
Retina-Vitreous Associates Medical Group
Beverly Hills, California 90211
United States
Bay Area Retina Associates
Walnut Creek, California 94598
United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland 21740
United States
Ophthalmological Center After S.V. Malayan
Yerevan, 0048
Armenia
Centre Monticelli Paradis d'Ophtalmologie
Marseille, 13008
France
Akhali Mzera Limited
Tbilisi, 0162
Georgia
Caucasus Medical Centre LLC
Tbilisi, 0186
Georgia
Chichua Medical Centre Mzera LLC
Tbilisi,
Georgia
Universitäts-Augenklinik Bonn
Bonn, 53127
Germany
Institute of Eye Surgery (IOES Waterford)
Waterford, X91 DH9W
Ireland
Hadassah Medical Center
Jerusalem, 9112001
Israel
Tel Aviv Medical Center
Tel Aviv, 6423906
Israel
Medical Retina & Imaging Unit, IRCCS MultiMedica, Ospedale San Giuseppe
Milan, Milano 20123
Italy
Unità di Oculistica, IRCCS Ospedale San Raffaele
Milan, Milano 20132
Italy