Promising ROd-cone DYstrophy Gene therapY (NCT05748873)
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)
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Bascom Palmer Eye Institute/University of Miami — Miami, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (6 Sites)
- Bascom Palmer Eye Institute/University of Miami — Miami, Florida
- Mass Eye and Ear — Boston, Massachusetts
- Casey Eye Institute — Portland, Oregon
- UPMC Eye Center — Pittsburgh, Pennsylvania
- Retina Foundation of the Southwest — Dallas, Texas
- CHNO XV-XX Paris - CIC 1423 — Paris,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.