Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration (NCT02286089)
🩺 Plain-English Summary (8th-Grade Level)
The main objective of the study is evaluation of the safety and tolerability of OpRegen - Human embryonic stem cell-derived retinal pigment epithelial (RPE) cells. The study will also include initial exploration of the ability of transplanted OpRegen cells to engraft, survive, and moderate disease progression.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (14 items).
Location: West Coast Retina Medical Group — San Francisco, 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:
- Evidence of neovascular AMD by history, as well as by clinical exam, fluorescein angiography (FA), or ocular coherence tomography (OCT) at baseline in either eye;
- History or presence of diabetic retinopathy, vascular occlusions, uveitis, Coat's disease, uncontrolled glaucoma, cataract or media opacity preventing posterior pole visualization or any significant ocular disease other than AMD that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome;
- History of retinal detachment repair in the study eye;
- Axial myopia greater than -6 diopters;
- At least 2 months following cataract removal in the study eye and Yttrium Aluminum Garnet (YAG) laser capsulotomy in the study eye in the past 4 weeks and any other ocular surgery in the study eye in the past 3 months prior to implantation;
- History of cognitive impairments or dementia;
- Contraindication for systemic immunosuppression;
- History of any condition other than AMD associated with choroidal neovascularization in the study eye (e.g. pathologic myopia or presumed ocular histoplasmosis);
- Any type of systemic disease or its treatment, in the opinion of the Investigator, including any medical condition (controlled or uncontrolled) 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 patient at special risk.
- Pregnancy or breastfeeding;
- Current participation in another clinical study. Past participation (within 6 months) in any clinical study of a drug administered systemically or to the eye.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (7 Sites)
- West Coast Retina Medical Group — San Francisco, California
- Cincinnati Eye Institute — Cincinnati, Ohio
- Mid Atlantic Retina — Philadelphia, Pennsylvania
- Hadassah Medical Center — Jerusalem,
- Rabin Medical Center — Petah Tikva,
- Kaplan Medical Center — Rehovot,
- Tel Aviv Sourasky Medical Center — 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.