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 (NCT05626114)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (13 items).
Location: Retina-Vitreous Associates Medical Group — Beverly Hills, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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
- Any cataract surgery or intraocular surgery within 3 months prior to subretinal surgical delivery of OpRegen
- History of other ocular or intraocular conditions that contraindicate the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications
- Any existing posterior segment device or implant Substudy: Inclusion Criteria: \- Participants must meet all of the inclusion criteria described in the parent study GR44251 and have the ability to comply with the substudy protocol Exclusion Criteria:
- Participants who meet any exclusion criteria listed in the parent study GR44251
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (17 Sites)
- Retina-Vitreous Associates Medical Group — Beverly Hills, California
- Retinal Consultants Medical Group — Sacramento, California
- West Coast Retina — San Francisco, California
- Retina Vitreous Associates of Florida — St. Petersburg, Florida
- The Retina Care Center — Baltimore, Maryland
- The Retina Institute — St Louis, Missouri
- Sierra Eye Associates — Reno, Nevada
- Duke Eye Center — Durham, North Carolina
- Cincinnati Eye Institute — Blue Ash, Ohio
- Mid Atlantic Retina — Philadelphia, Pennsylvania
- Tennessee Retina PC — Nashville, Tennessee
- Austin Clinical Research, LLC — Austin, Texas
- Retina Consultants of Texas — Bellaire, Texas
- Piedmont Eye Center — Lynchburg, Virginia
- Spokane Eye Clinical Research;Spokane Eye Surgery Center — Spokane, Washington
- Hadassah MC — Jerusalem,
- Tel Aviv Sourasky MC — Tel Aviv,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.