Trials / Recruiting
RecruitingNCT05748873
Promising ROd-cone DYstrophy Gene therapY
A Phase I/II Study to Assess the Safety and Tolerability of a Single Subretinal Administration of SPVN06 Gene Therapy in Subjects With Rod-Cone Dystrophy (RCD) Due to a Mutation in the RHO, PDE6A, or PDE6B Gene
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- Sponsor
- SparingVision · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a two-step, multicenter, Phase I/II study including an open-label dose-escalation phase (Step 1) and a three-arm, controlled, double-masked, randomized extension phase (Step 2), in subjects with advanced RCD due to a mutation in the RHO, PDE6A, or PDE6B gene.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SPVN06 | AAV-RdCVF-RdCVFL |
Timeline
- Start date
- 2023-04-12
- Primary completion
- 2025-09-01
- Completion
- 2030-09-01
- First posted
- 2023-03-01
- Last updated
- 2025-09-16
Locations
6 sites across 2 countries: United States, France
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05748873. Inclusion in this directory is not an endorsement.