A Phase 2 interventional study of OpRegen in Geographic Atrophy, sponsored by Genentech, Inc.. Recruiting at 17 sites in 2 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Genentech, Inc. (part of Hoffmann-La Roche) · Phase 2, Interventional, and Treatment
Among 131 studies in Geographic Atrophy with a site in United States — 35 open to participants now, 46 under way, 5 of them phase 3. Geographic Atrophy · United States.
Among the 131 studies in Geographic Atrophy with a site in United States, this one is the 65th largest by planned enrollment of the 107 interventional ones, is one of 12 that started in 2023, is one of 43 in phase 2, reaches primary completion later than 45 of the 45 other live ones, and was the 85th registered.
188 studies on the registry are indexed under Geographic Atrophy; 52 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 141 interventional studies indexed under Geographic Atrophy.
Browse Geographic Atrophy studies →35 of the 131 studies in Geographic Atrophy with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 40 Geographic Atrophy studies recruiting now, 31 (78%) set no upper age limit and 0 (0%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 50 Years and older · all sexes · no healthy volunteers.
The full table on the hub →131 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 12 started in 2023.
Median enrollment 98 across the 107 interventional studies, 138 across the 24 observational. Of the 78 that completed or were terminated, 40 (51%) have results posted.
109 of 131 have an industry lead sponsor. The 10 most frequent:
Genentech, Inc. is the lead sponsor of 517 studies on the registry; 20 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 52 (55%) have results posted.
Genentech, Inc. has 9 studies filed under Geographic Atrophy — fewer than ten, so there is no comparison to draw.
12 of the studies in Geographic Atrophy with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05949593Phase 3Belite Bio, IncPhase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy | 2027-06-30 |
| NCT06510816Phase 3Annexon, Inc.A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA) | 2027-07-31 |
| NCT06769048Boehringer IngelheimA Study to Test Different Doses of BI 1584862 in People With a Distinct Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy | 2026-12-22 |
| NCT07747662University of Wisconsin, MadisonAdaptive Optics Scanning Light Ophthalmoscopy (AOSLO) and Microperimetry (MP) Sub-study | 2027-02 |
| NCT07144137Complement TherapeuticsA Non-Interventional Study Observing Short-Term Progression in Geographic Atrophy (GA) | 2027-03-31 |
Among the 131 studies in Geographic Atrophy with a site in United States, from their registry updates:
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 Criteria:
Exclusion Criteria:
Ocular Exclusion Criteria for Study Eye:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
OpRegen dose of up to approximately 200,000 cells will be delivered into the subretinal space.
Biological: OpRegen
OpRegen dose of up to approximately 200,000 cells will be delivered into the subretinal space.
Proportion of Participants With Subretinal Surgical Delivery of OpRegen to Target Regions
Time frame: 3 months post-surgery
Incidence and Severity of Procedure-related Adverse Events (AEs) at 3 Months Following Surgery
Time frame: 3 months post-surgery
Proportion of Participants With Qualitative Improvement in Retinal Structure, as Determined by Optical Coherence Tomography (OCT) Imaging Within 3 Months Following Surgery
Time frame: 3 months post-surgery
Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
Started Mar 2023 (actual). Primary completion is estimated for Mar 2031, 95 months after the start.
Of 24 phase 2 interventional studies under Geographic Atrophy, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 54. This study's planned 95 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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