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)

Study 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).

Interventions

Study Locations

Facility	City	State	Country
Bascom Palmer Eye Institute/University of Miami	Miami	Florida	United States
Mass Eye and Ear	Boston	Massachusetts	United States
Casey Eye Institute	Portland	Oregon	United States
UPMC Eye Center	Pittsburgh	Pennsylvania	United States
Retina Foundation of the Southwest	Dallas	Texas	United States
CHNO XV-XX Paris - CIC 1423	Paris		France

Official Trial Information

View on ClinicalTrials.gov