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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 is a Phase 3 study of Optic, Atrophy, Hereditary, Leber that has completed, run by GenSight Biologics. The registered enrollment target is 37 participants. The trial reports 7 study locations across 6 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02652780
The ClinicalTrials.gov registry entry for NCT02652780 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 37 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 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 reports 7 study locations spanning 6 distinct geographic areas - top geographies include 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.
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