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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: Recruiting Phase 2 study of Geographic Atrophy, sponsored by Genentech.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 60 participants
Start Date 2023-03-23
Est. Completion 2031-03-01
Phase Phase 2
Genentech

332 total trials

What NCT05626114 shows while recruiting

NCT05626114 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 220-participant average among 27 other Geographic Atrophy trials with a reported enrollment target (73% lower).

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 lists 17 locations in 13 states (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.

Similar trials for Geographic Atrophy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05626114's enrollment target sits among peer trials

60 20th of 27 higher than 6 of 27 other Geographic Atrophy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Geographic Atrophy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05626114, the US trial registry maintained by the National Library of Medicine. NCT05626114 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.