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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
OpRegen dose of up to approximately 200,000 cells will be delivered into the subretinal space.
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
RECRUITINGRetinal Consultants Medical Group
Sacramento, California, United States
RECRUITINGWest Coast Retina
San Francisco, California, United States
RECRUITINGRetina Vitreous Associates of Florida
St. Petersburg, Florida, United States
RECRUITINGThe Retina Care Center
Baltimore, Maryland, United States
RECRUITINGThe Retina Institute
St Louis, Missouri, United States
RECRUITINGSierra Eye Associates
Reno, Nevada, United States
RECRUITINGCincinnati Eye Institute
Blue Ash, Ohio, United States
RECRUITINGMid Atlantic Retina
Philadelphia, Pennsylvania, United States
RECRUITINGTennessee Retina PC
Nashville, Tennessee, United States
RECRUITING...and 6 more locations
Proportion of Participants With Subretinal Surgical Delivery of OpRegen to Target Regions
Time frame: 3 months post-surgery
Incidence and Severity of Procedure-related Adverse Events (AEs) at 3 Months Following Surgery
Time frame: 3 months post-surgery
Proportion of Participants With Qualitative Improvement in Retinal Structure, as Determined by Optical Coherence Tomography (OCT) Imaging Within 3 Months Following Surgery
Time frame: 3 months post-surgery
Reference Study ID Number: GR44251 https://forpatients.roche.com/
CONTACT
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