Ray Therapeutics, Inc.
The purpose of this clinical trial is to evaluate the effectiveness and safety of a single injection into the eye of an investigational gene therapy in participants with retinitis pigmentosa (RP).
In this Phase 2/3, double-masked study, approximately 60 eligible participants with RP will be enrolled and randomized to receive in the study eye either a single, unilateral intravitreal injection of lower dose RTx-015, higher dose RTx-015, or a sham injection. Participants who meet all eligibility criteria will be randomized in a 1:1:1 ratio. Participants will be followed for a total of 12 months.
Inclusion Criteria: * Adults ≥18 years of age at the time of informed consent. * Able and willing to provide written informed consent prior to any study-specific procedures, in accordance with ICH GCP and applicable regulations. * Clinical diagnosis of RP, regardless of the underlying genetic mutation * Baseline best corrected distance visual acuity (BCVA) in the study eye of LogMAR 1.0 and 2.7 inclusive (approximately 20/200 - 20/9000), measured monocularly at the ETF by certified, masked personnel using grating visual acuity with conversion to logMAR equivalents. * Presence of retinal gangl…
Intravitreal injection
Sham Control