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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 is a Phase 3 study that has completed, run by GenSight Biologics. The registered enrollment target is 39 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02652767
The ClinicalTrials.gov registry entry for NCT02652767 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GenSight Biologics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which GS010 is the first listed.
NCT02652767 reports 0 study locations.
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.
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