drugset / Trial / NCT07439887

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

NCT07439887 ↗

Phase 1/2 Recruiting 18 enrolled Ray Therapeutics, Inc.
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2026-01-28
Primary completion
2030-12-01
Completion
2030-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject RTx-021 Gene therapy (AAV / viral vector) — Intravitreal

Indications