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NCT02652767 · ClinicalTrials.gov registry record · Phase 3
Efficacy Study of GS010 for the Treatment of Vision Loss up to 6 Months From Onset in LHON Due to the ND4 Mutation
A Phase 3 study, sponsored by GenSight Biologics.
- Completed
- Registry status
- Phase 3
- Development phase
- 39
- Enrollment target
NCT02652767: Completed Phase 3 study, sponsored by GenSight Biologics.
NCT02652767 is a Phase 3 study that has completed, run by GenSight Biologics. The registered enrollment target is 39 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02652767, a Phase 3 study, has completed, sponsored by GenSight Biologics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 39 participants
- Enrollment target
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 six months or less.
Primary Outcome
Visual acuity was derived from the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Visual acuity is measured in "logarithm of the minimal angle of resolution" (LogMAR), which 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. A positive change from baseline indicates a worsening in symptoms. Change = (Week 48 score - Baseline score).
Interventions
- BIOLOGICAL GS010
- DEVICE Sham Intravitreal Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2016-02-23 |
| Est. Completion | 2019-07-04 |
| Phase | Phase 3 |
What the finished NCT02652767 record still lists
NCT02652767 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 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 0 conditions, and to 2 interventions - of which GS010 is the first listed.
NCT02652767 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02652767 about?
NCT02652767 is a clinical study titled "Efficacy Study of GS010 for the Treatment of Vision Loss up to 6 Months From Onset in LHON Due to the ND4 Mutation". 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 six months or less.
What is the current status of trial NCT02652767?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 39 participants. The study started on 2016-02-23. Estimated completion is 2019-07-04.
What interventions are being tested in trial NCT02652767?
The interventions under investigation include: GS010 (BIOLOGICAL), Sham Intravitreal Injection (DEVICE).
Who is sponsoring clinical trial NCT02652767?
This trial is sponsored by GenSight Biologics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02652767's enrollment target sits among peer trials
39 1898th of 2000 higher than 101 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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