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.
Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care
Diagnosis of GA secondary to AMD
Best corrected visual acuity (BCVA) score ≥ 29 letters and ≤ 60 letters in the study eye as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS)
Pseudophakic (study eye)
Pregnancy or breastfeeding
History of cognitive impairment or dementia
Any type of systemic disease or its treatment, in the opinion of the investigator, including any medical conditions that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the participant to a significant degree or put the participant at special risk
Any current or history of ocular disease other than GA that may confound assessment of the macula
Single group
OpRegen
Biological/VaccineOpRegen dose of up to approximately 200,000 cells will be delivered into the subretinal space.
Proportion of Participants With Subretinal Surgical Delivery of OpRegen to Target Regions
Incidence and Severity of Procedure-related Adverse Events (AEs) at 3 Months Following Surgery
Proportion of Participants With Qualitative Improvement in Retinal Structure, as Determined by Optical Coherence Tomography (OCT) Imaging Within 3 Months Following Surgery
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