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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
NCT05626114 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL OpRegen
Study Locations (17)
California
- Retina-Vitreous Associates Medical Group — Beverly Hills
- Retinal Consultants Medical Group — Sacramento
- West Coast Retina — San Francisco
Texas
- Austin Clinical Research, LLC — Austin
- Retina Consultants of Texas — Bellaire
Other
- Hadassah MC — Jerusalem
- Tel Aviv Sourasky MC — Tel Aviv
Florida
- Retina Vitreous Associates of Florida — St. Petersburg
Maryland
- The Retina Care Center — Baltimore
Missouri
- The Retina Institute — St Louis
Nevada
- Sierra Eye Associates — Reno
North Carolina
- Duke Eye Center — Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-03-23 |
| Est. Completion | 2031-03-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05626114
The ClinicalTrials.gov registry entry for NCT05626114 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 206 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Geographic Atrophy appearing as the primary indexed condition, and to 1 intervention — of which OpRegen is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05626114 reports 17 study locations spanning 13 distinct geographic areas — top geographies include California, Texas, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05626114 about?
NCT05626114 is a clinical study titled "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". 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. T...
What is the current status of trial NCT05626114?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2023-03-23. Estimated completion is 2031-03-01.
What conditions does trial NCT05626114 study?
This clinical trial studies the following conditions: Geographic Atrophy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05626114?
The interventions under investigation include: OpRegen (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05626114?
This trial is sponsored by Genentech, which has 206 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05626114 being conducted?
This trial has 17 study locations across California, Florida, Maryland, Missouri, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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