NCT05626114RecruitingPhase 2
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
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
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 15 Nov 2022
- Start date
- 23 Mar 2023
- Primary completion date
- 1 Mar 2031
- Lead sponsor
- Genentech, Inc.
- Diseases
- Macular degeneration
- NCT number
- NCT05626114
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 23 Mar 2023 to the primary completion date, 1 Mar 2031
- 17 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
Other illness
- 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
Other
- Pregnancy or breastfeeding
- Uncontrolled glaucoma or advanced glaucoma
- Participants who meet any exclusion criteria listed in the parent study GR44251
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hadassah MC Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Tel-Aviv Sourasky MC Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| Austin Clinical Research, LLC Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| The Retina Care Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | Bellaire | United States | Recruiting |
| Retina-Vitreous Associates Medical Group Coordinator of this site? Confirm its status | Beverly Hills | United States | Recruiting |
| Cincinnati Eye Institute Coordinator of this site? Confirm its status | Blue Ash | United States | Recruiting |
| Duke Eye Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Piedmont Eye Center Coordinator of this site? Confirm its status | Lynchburg | United States | Recruiting |
| Tennessee Retina, PC Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Mid Atlantic Retina Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Sierra Eye Associates Coordinator of this site? Confirm its status | Reno | United States | Recruiting |
| Retinal Consultants Medical Group Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| West Coast Retina Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Spokane Eye Clinical Research;Spokane Eye Surgery Center Coordinator of this site? Confirm its status | Spokane | United States | Recruiting |
| The Retina Institute Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Retina Vitreous Associates of Florida Coordinator of this site? Confirm its status | St. Petersburg | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.