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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.
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
Conditions
Interventions
RTx-021
Optogenetic gene therapy
Locations (2)
RayTx Clinical Site
Bakersfield, California, United States
RayTx Clinical Site
Bellaire, Texas, United States