Phase
Condition
Macular Degeneration
Geographic Atrophy
Treatment
OpRegen
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Ability to undergo a vitreoretinal surgical procedure under monitored anesthesiacare
Diagnosis of GA secondary to AMD
Best corrected visual acuity (BCVA) score ≥ 29 letters and ≤ 60 letters in the studyeye as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS)
Pseudophakic (study eye)
Exclusion
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, orchange to such an extent that it may bias the assessment of the clinical status ofthe 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 assessmentof 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 subretinalsurgical delivery of OpRegen
History of other ocular or intraocular conditions that contraindicate the use of aninvestigational drug or may affect interpretation of the study results or may renderthe 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
Past history of seizures, or epileptic seizures due to any cause except for a singlefebrile seizure in childhood
Study Design
Connect with a study center
Hadassah MC
Jerusalem, 9112001
IsraelActive - Recruiting
Hadassah MC; Ophtalmology
Jerusalem, 9112001
IsraelActive - Recruiting
Hadassah MC
Jerusalem 281184, 9112001
IsraelSite Not Available
Tel Aviv Sourasky MC
Tel Aviv, 6423906
IsraelActive - Recruiting
Tel Aviv Sourasky MC
Tel Aviv 293397, 6423906
IsraelSite Not Available
Retina-Vitreous Associates Medical Group
Beverly Hills, California 90211
United StatesActive - Recruiting
Retinal Consultants Medical Group
Sacramento, California 95825
United StatesActive - Recruiting
West Coast Retina
San Francisco, California 94109-5520
United StatesActive - Recruiting
Retina-Vitreous Associates Medical Group
Beverly Hills 5328041, California 5332921 90211
United StatesSite Not Available
Retinal Consultants Medical Group
Sacramento 5389489, California 5332921 95825
United StatesSite Not Available
West Coast Retina
San Francisco 5391959, California 5332921 94109-5520
United StatesSite Not Available
Retina Vitreous Associates of Florida
St. Petersburg, Florida 33711
United StatesActive - Recruiting
Retina Vitreous Associates of Florida
St. Petersburg 4171563, Florida 4155751 33711
United StatesSite Not Available
The Retina Care Center
Baltimore, Maryland 21209-2219
United StatesActive - Recruiting
The Retina Care Center
Baltimore 4347778, Maryland 4361885 21209-2219
United StatesSite Not Available
The Retina Institute
Saint Louis, Missouri 63128-1729
United StatesSite Not Available
The Retina Institute
St Louis, Missouri 63128-1729
United StatesActive - Recruiting
The Retina Institute
St Louis 4407066, Missouri 4398678 63128-1729
United StatesSite Not Available
Sierra Eye Associates
Reno, Nevada 89502-1605
United StatesActive - Recruiting
Sierra Eye Associates
Reno 5511077, Nevada 5509151 89502-1605
United StatesSite Not Available
Mid Atlantic Retina
Cherry Hill, New Jersey 08034
United StatesSite Not Available
Duke Eye Center
Durham, North Carolina 27705-4699
United StatesActive - Recruiting
Duke Eye Center
Durham 4464368, North Carolina 4482348 27705-4699
United StatesSite Not Available
Cincinnati Eye Institute
Blue Ash, Ohio 45242-5537
United StatesActive - Recruiting
Cincinnati Eye Institute
Cincinnati, Ohio 45242
United StatesSite Not Available
Cincinnati Eye Institute
Blue Ash 4506754, Ohio 5165418 45242-5537
United StatesSite Not Available
Mid Atlantic Retina
Philadelphia, Pennsylvania 19107-5109
United StatesActive - Recruiting
Mid Atlantic Retina
Philadelphia 4560349, Pennsylvania 6254927 19107-5109
United StatesSite Not Available
Tennessee Retina PC
Nashville, Tennessee 37203-1513
United StatesActive - Recruiting
Tennessee Retina PC
Nashville 4644585, Tennessee 4662168 37203-1513
United StatesSite Not Available
Austin Clinical Research, LLC
Austin, Texas 78750-2298
United StatesActive - Recruiting
Retina Consultants of Texas
Bellaire, Texas 77401
United StatesActive - Recruiting
Austin Clinical Research, LLC
Austin 4671654, Texas 4736286 78750-2298
United StatesSite Not Available
Retina Consultants of Texas
Bellaire 4673353, Texas 4736286 77401
United StatesSite Not Available
Piedmont Eye Center
Lynchburg, Virginia 24502-4271
United StatesActive - Recruiting
Piedmont Eye Center
Lynchburg 4771075, Virginia 6254928 24502-4271
United StatesSite Not Available
Spokane Eye Clinical Research;Spokane Eye Surgery Center
Spokane, Washington 99204
United StatesActive - Recruiting
Spokane Eye Clinical Research;Spokane Eye Surgery Center
Spokane 5811696, Washington 5815135 99204
United StatesSite Not Available

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