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RECRUITING
NCT07439887
PHASE1/PHASE2

Phase 1/2 Open-Label Dose-Escalation Study to Evaluate Safety of a Single Intravitreal Injection of RTx-021 in Patients With Stargardt Disease

Sponsor: Ray Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

A Phase 1/2, open-label, non-randomized, dose-escalation study, where a minimum of 9 and a maximum of 18 eligible patients with Stargardt Disease will be enrolled sequentially in up to 3 dose cohorts of RTx-021. Enrolled patients will receive a single, unilateral intravitreal injection of RTx-021 in the study eye and be followed for 5 years.

Official title: Phase 1/2, Open-Label, Dose-Escalation Study to Evaluate Safety of a Single Intravitreal Injection of RTx-021 in Patients With Stargardt Disease (AURORA)

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2026-01-28

Completion Date

2030-12-01

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

GENETIC

RTx-021

Optogenetic gene therapy

Locations (2)

RayTx Clinical Site

Bakersfield, California, United States

RayTx Clinical Site

Bellaire, Texas, United States