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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
Sponsor: Genentech, Inc.
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.
Official title: A Phase IIa, Multicenter, Open-label, Single-Arm Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2023-03-23
Completion Date
2031-03-01
Last Updated
2026-03-23
Healthy Volunteers
No
Conditions
Interventions
OpRegen
OpRegen dose of up to approximately 200,000 cells will be delivered into the subretinal space.
Locations (17)
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Retinal Consultants Medical Group
Sacramento, California, United States
West Coast Retina
San Francisco, California, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
The Retina Care Center
Baltimore, Maryland, United States
The Retina Institute
St Louis, Missouri, United States
Sierra Eye Associates
Reno, Nevada, United States
Duke Eye Center
Durham, North Carolina, United States
Cincinnati Eye Institute
Blue Ash, Ohio, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States
Tennessee Retina PC
Nashville, Tennessee, United States
Austin Clinical Research, LLC
Austin, Texas, United States
Retina Consultants of Texas
Bellaire, Texas, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Spokane Eye Clinical Research;Spokane Eye Surgery Center
Spokane, Washington, United States
Hadassah MC
Jerusalem, Israel
Tel Aviv Sourasky MC
Tel Aviv, Israel