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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
110
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
RECRUITINGBay Area Retina Associates
Walnut Creek, California, United States
RECRUITINGCumberland Valley Retina Consultants
Hagerstown, Maryland, United States
RECRUITINGOphthalmological Center After S.V. Malayan
Yerevan, Armenia
RECRUITINGCentre Monticelli Paradis d'Ophtalmologie
Marseille, France
RECRUITINGAkhali Mzera Limited
Tbilisi, Georgia
RECRUITINGCaucasus Medical Centre LLC
Tbilisi, Georgia
RECRUITINGChichua Medical Centre Mzera LLC
Tbilisi, Georgia
RECRUITINGUniversitäts-Augenklinik Bonn
Bonn, Germany
RECRUITINGInstitute of Eye Surgery (IOES Waterford)
Waterford, Ireland
RECRUITING...and 4 more locations
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).
Time frame: From baseline to last on-treatment visit (48 up to 96 weeks)
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)
Time frame: From baseline to last on-treatment visit (48 up to 96 weeks)
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