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NCT05626114 · ClinicalTrials.gov registry record · Phase 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 2 study of Geographic Atrophy, sponsored by Genentech.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 17
- Study locations
NCT05626114 is a Phase 2 study of Geographic Atrophy that is actively recruiting participants, run by Genentech. The registered enrollment target is 60 participants, below the 220-participant average among 27 other Geographic Atrophy trials with a reported enrollment target (73% lower). The trial reports 17 study locations across 13 states.
The verdict
NCT05626114, a Phase 2 study of Geographic Atrophy, is actively recruiting participants, sponsored by Genentech.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 17
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 220-participant average among 27 other Geographic Atrophy trials with a reported enrollment target (73% lower). The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
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.
NCT05626114 reports 17 study locations spanning 13 distinct geographic areas - top geographies include California, Texas, Other.
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.
What interventions are being tested in trial NCT05626114?
The interventions under investigation include: OpRegen (BIOLOGICAL).
Who is sponsoring clinical trial NCT05626114?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.