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Study to Evaluate Safety of RTx-015 Injection in Retinitis Pigmentosa Patients

Retinitis Pigmentosa Clinical Trial

Official title:
Phase 1, Open-Label, Dose-Escalation Study to Evaluate Safety of a Single Intravitreal Injection of RTx-015 in Patients With Retinitis Pigmentosa

Clinical Trial Summary

A Phase 1, open-label, non-randomized, dose-escalation study, where approximately 9 eligible patients with retinitis pigmentosa will be enrolled sequentially in up to 3 dose cohorts of RTx-015. Enrolled patients will receive a single, unilateral intravitreal injection of RTx-015 in the study eye at Visit 3 (Day 0) and be followed for a total of 12 months.

Clinical Trial Description

This Phase 1, open-label, non-randomized, multicenter clinical trial is to evaluate the safety and preliminary efficacy of a single, uniocular intravitreal injection of an investigational optogenetic gene therapy, RTx-015, in patients with retinitis pigmentosa. Up to 3 dose cohorts are planned, and each cohort will consist initially of 3 patients. Eligible patients will be assigned to a dose cohort by sequential enrollment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06460844
Study type Interventional
Source Ray Therapeutics, Inc.
Contact Executive Medical Director
Phone +1 858 617 8610
Email clinicaltrials@raytherapeutics.com
Status Not yet recruiting
Phase Phase 1
Start date August 2024
Completion date May 2026
View Details
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