RecruitingGeographic Atrophy

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

Eligible age

50+ yrs

Accepts

All genders

Locations

12 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

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.

Sponsor: Genentech, Inc.

You may qualify if…

✓ 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)
✓ \- Participants must meet all of the inclusion criteria described in the parent study GR44251 and have the ability to comply with the substudy protocol

You may not qualify if…

✕ 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
✕ Ocular Exclusion Criteria for Study Eye:
✕ Any current or history of ocular disease other than GA that may confound assessment of the macula
✕ History of retinal detachment
✕ History of vitrectomy, glaucoma-filtering surgery, or corneal transplant
✕ Uncontrolled glaucoma or advanced glaucoma