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ACTIVE NOT RECRUITING
NCT06460844
PHASE1

Study to Evaluate Safety of RTx-015 Injection in Retinitis Pigmentosa or Choroideremia Patients (ENVISION)

Sponsor: Ray Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

A Phase 1, open-label, non-randomized, dose-escalation study, where approximately 18 eligible patients with retinitis pigmentosa or choroideremia will be enrolled sequentially in up to 4 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 5 years.

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 or Choroideremia (ENVISION)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2024-08-27

Completion Date

2030-10

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

GENETIC

RTx-015

Intravitreal injection using gene therapy to deliver an optogenetic gene to the eye. Cells in the retina use this Optogenetic gene to make a protein that responds to light.

Locations (4)

Retina Vitreous Associates Medical Group

Beverly Hills, California, United States

UCI Alpha Clinic

Orange, California, United States

UPMC Vision Institute

Pittsburgh, Pennsylvania, United States

Retina Consultants of Texas Research Centers

Bellaire, Texas, United States