Tests OpRegen cell therapy in people with geographic atrophy from macular degeneration
Tests OpRegen, a cell therapy delivered under the retina, in adults with geographic atrophy.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Austin, Baltimore, Bellaire, Beverly Hills, Blue Ash, Durham, Lynchburg, Nashville, Philadelphia, Reno, Sacramento, San Francisco, Spokane, St Louis, and St. Petersburg, United StatesSee the 15 sites
- Phase
- Phase 2
Where in United States
- Austin Clinical Research, LLCAustin, United StatesTaking people
- The Retina Care CenterBaltimore, United StatesTaking people
- Retina Consultants of TexasBellaire, United StatesTaking people
- Retina-Vitreous Associates Medical GroupBeverly Hills, United StatesTaking people
- Cincinnati Eye InstituteBlue Ash, United StatesTaking people
- Duke Eye CenterDurham, United StatesTaking people
- Piedmont Eye CenterLynchburg, United StatesTaking people
- Tennessee Retina, PCNashville, United StatesTaking people
- Mid Atlantic RetinaPhiladelphia, United StatesTaking people
- Sierra Eye AssociatesReno, United StatesTaking people
- Retinal Consultants Medical GroupSacramento, United StatesTaking people
- West Coast RetinaSan Francisco, United StatesTaking people
- Spokane Eye Clinical Research;Spokane Eye Surgery CenterSpokane, United StatesTaking people
- The Retina InstituteSt Louis, United StatesTaking people
- Retina Vitreous Associates of FloridaSt. Petersburg, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Genentech, Inc.
- Trial code
- NCT05626114
- Record updated
- 14 October 2026
- Original description
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.Read full original descriptionShow less
A Phase IIa, Multicenter, Open-label, Single-Arm Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
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.
Inclusion: 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.
Exclusion: 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:; 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; Past history of seizures, or epileptic seizures due to any cause except for a single febrile seizure in childhood; Pregnancy or breastfeeding; Uncontrolled glaucoma or advanced glaucoma; Participants who meet any exclusion criteria listed in the parent study GR44251.