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NCT02652780 · ClinicalTrials.gov registry record · Phase 3
Efficacy Study of GS010 for Treatment of Vision Loss From 7 Months to 1 Year From Onset in LHON Due to the ND4 Mutation (REVERSE)
A Phase 3 study of Optic, Atrophy, Hereditary, Leber, sponsored by GenSight Biologics.
- Completed
- Registry status
- Phase 3
- Development phase
- 37
- Enrollment target
- 7
- Study locations
NCT02652780: Completed Phase 3 study of Optic, Atrophy, Hereditary, Leber, sponsored by GenSight Biologics.
NCT02652780 is a Phase 3 study of Optic, Atrophy, Hereditary, Leber that has completed, run by GenSight Biologics. The registered enrollment target is 37 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02652780, a Phase 3 study of Optic, Atrophy, Hereditary, Leber, has completed, sponsored by GenSight Biologics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 37 participants
- Enrollment target
- 7
- Study locations
Study Summary
The goal of this clinical trial is to assess the effectiveness of GS010, a gene therapy, in improving the visual outcome in participants with Leber Hereditary Optic Neuropathy (LHON) due to the G11778A ND4 mitochondrial mutation when vision loss is present for more than six months and up to one year.
Primary Outcome
Visual acuity was derived from the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The visual acuity logarithm of the minimal angle of resolution (LogMAR) score was derived from the number of letters participants could read on the ETDRS chart. 1 ETDRS line = 5 letters 1 ETDRS line = 0.1 LogMAR A lower LogMAR score denotes better visual acuity and a negative change from baseline indicates an improvement in visual acuity. Change = (Week 48 score - Baseline score).
Conditions Studied
Interventions
- BIOLOGICAL GS010
- DEVICE Sham Intravitreal Injection
Study Locations (7)
Other
- Department of Neurology, University of Munich, Friedrich-Baur-Institute - Munich
- Moorfields Eye Hospital NHS Foundation Trust - London
California
- Doheny Eye Center, University of California, Los Angeles - Los Angeles
Georgia
- Department of Ophthalmology, Emory University School of Medicine - Atlanta
Pennsylvania
- Neuro Ophthalmologic Associates, Wills Eye Hospital, Thomas Jefferson University - Philadelphia
Paris
- Centre National Hospitalier d'Ophtalmologie des Quinze-Vingt - Paris
Bologna
- IRCCS Istituto delle Scienze Neurologiche di Bologna, UOC Clinica Neurologica, Ospedale Bellaria - Bologna
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2016-01 |
| Est. Completion | 2018-12 |
| Phase | Phase 3 |
What the finished NCT02652780 record still lists
NCT02652780 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Optic, Atrophy, Hereditary, Leber appearing as the primary indexed condition, and to 2 interventions - of which GS010 is the first listed.
NCT02652780 lists 7 locations in 6 states (Other, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT02652780 about?
NCT02652780 is a clinical study titled "Efficacy Study of GS010 for Treatment of Vision Loss From 7 Months to 1 Year From Onset in LHON Due to the ND4 Mutation (REVERSE)". The goal of this clinical trial is to assess the effectiveness of GS010, a gene therapy, in improving the visual outcome in participants with Leber Hereditary Optic Neuropathy (LHON) due to the G11778A ND4 mitochondrial mutation when vision loss is present for more than six months and up to one year...
What is the current status of trial NCT02652780?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 37 participants. The study started on 2016-01. Estimated completion is 2018-12.
What conditions does trial NCT02652780 study?
This clinical trial studies the following conditions: Optic, Atrophy, Hereditary, Leber.
What interventions are being tested in trial NCT02652780?
The interventions under investigation include: GS010 (BIOLOGICAL), Sham Intravitreal Injection (DEVICE).
Who is sponsoring clinical trial NCT02652780?
This trial is sponsored by GenSight Biologics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02652780 being conducted?
This trial has 7 study locations across California, Georgia, Pennsylvania, Paris, Bologna. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02652780's enrollment target sits among peer trials
37 1901st of 2000 higher than 100 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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