Promising ROd-cone DYstrophy Gene therapY
NCT05748873 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2026-05-15
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 (Step 1), or in any RCD-causative gene (Step 2).
Conditions
Interventions
- DRUG
-
SPVN06
AAV-RdCVF-RdCVFL
Sponsors & Collaborators
-
SparingVision
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-12
- Primary Completion
- 2027-02-28
- Completion
- 2031-02-28
- FDA Drug
- Yes
Countries
- United States
- France
Study Locations
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