drugset / Trial / NCT07303296
Efficacy and Safety Study of Bilateral IVT Injection of GS010 at Two Dose Levels in LHON Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this Clinical trial is to assess the safety and efficacy of GS010 at two dose levels on visual acuity and retinal mitochondrial activity in patients affected with ND4 Leber Hereditary Optic Neuropathy (LHON)
Timeline
- Start
- 2026-01-22
- Primary completion
- 2028-05-15
- Completion
- 2028-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | GS010 | Gene therapy (AAV / viral vector) | 1.3e+11 vg | Intravitreal |
| Comparator | GS010 | Gene therapy (AAV / viral vector) | 3.9e+11 vg | Intravitreal |