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
NCT ID: NCT05626114
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2023-03-23
2031-03-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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OpRegen
OpRegen dose of up to approximately 200,000 cells will be delivered into the subretinal space.
OpRegen
OpRegen dose of up to approximately 200,000 cells will be delivered into the subretinal space.
Interventions
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OpRegen
OpRegen dose of up to approximately 200,000 cells will be delivered into the subretinal space.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
* 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:
* Past history of seizures, or epileptic seizures due to any cause except for a single febrile seizure in childhood
50 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Retinal Consultants Medical Group
Sacramento, California, United States
West Coast Retina
San Francisco, California, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
The Retina Care Center
Baltimore, Maryland, United States
The Retina Institute
St Louis, Missouri, United States
Cincinnati Eye Institute
Blue Ash, Ohio, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States
Tennessee Retina PC
Nashville, Tennessee, United States
Austin Clinical Research, LLC
Austin, Texas, United States
Retina Consultants of Texas
Bellaire, Texas, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Spokane Eye Clinical Research;Spokane Eye Surgery Center
Spokane, Washington, United States
Hadassah MC
Jerusalem, , Israel
Tel Aviv Sourasky MC
Tel Aviv, , Israel
Countries
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Central Contacts
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Reference Study ID Number: GR44251 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S. Only)
Email: [email protected]
References
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Aweidah H, Matsevich C, Khaner H, Idelson M, Ejzenberg A, Reubinoff B, Banin E, Obolensky A. Survival of Neural Progenitors Derived from Human Embryonic Stem Cells Following Subretinal Transplantation in Rodents. J Ocul Pharmacol Ther. 2023 Jun;39(5):347-358. doi: 10.1089/jop.2022.0161. Epub 2023 May 4.
Other Identifiers
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GR44251
Identifier Type: -
Identifier Source: org_study_id