A Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GAlette); Adaptive Optics (AO) Retinal Imaging Substudy in Association With Study GR44251
Start Date
3/23/2023
Completion Date
3/1/2031
Summary
This study will evaluate the success and safety of subretinal surgical delivery as well as the preliminary activity of OpRegen in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). All endpoints are assessed for the study eye unless otherwise indicated. The substudy will evaluate the operational feasibility and scientific interpretability of incorporating AO retinal imaging using the EarlySight Cellularis® Discovery device. Participants who have fulfilled the eligibility requirements for the parent study and meet the substudy's eligibility criteria will have the option to participate in the substudy. The EarlySight Cellularis® Discovery device will be used only as an assessment tool and data obtained from this device will not be used to guide clinical care or influence clinical outcomes for participants.
Eligibility Criteria
Age Range: 50 years to No maximum
Interventions
OpRegen
Conditions
Locations
Retina-Vitreous Associates Medical Group
Beverly Hills, California 90211
United States
Retinal Consultants Medical Group
Sacramento, California 95825
United States
West Coast Retina
San Francisco, California 94109-5520
United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida 33711-1141
United States
The Retina Care Center
Baltimore, Maryland 21209-2219
United States
The Retina Institute
St Louis, Missouri 63128-1729
United States
Sierra Eye Associates
Reno, Nevada 89502-1605
United States
Duke Eye Center
Durham, North Carolina 27705-4699
United States
Cincinnati Eye Institute
Blue Ash, Ohio 45242-5537
United States
Mid Atlantic Retina
Philadelphia, Pennsylvania 19107-5109
United States
Tennessee Retina PC
Nashville, Tennessee 37203-1513
United States
Austin Clinical Research, LLC
Austin, Texas 78750-2298
United States
Retina Consultants of Texas
Bellaire, Texas 77401
United States
Piedmont Eye Center
Lynchburg, Virginia 24502-4271
United States
Spokane Eye Clinical Research;Spokane Eye Surgery Center
Spokane, Washington 99204
United States
Hadassah MC
Jerusalem, 9112001
Israel
Tel Aviv Sourasky MC
Tel Aviv, 6423906
Israel