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.
Male and female patients >= 16 years of age
Able to comply with the study visit schedule and all protocol assessments
Diagnosis of Stargardt Disease (genetic testing required)
Study eye and fellow eye Best Corrected Visual Acuity meeting study criteria
Participation in a clinical study (ocular or non-ocular) with an investigational drug, agent, or therapy in the past six months
Concurrent participation in another interventional clinical ocular study
Prior receipt of any gene therapy (ocular or other), retinal implant, or ocular cell therapy
Pre-existing eye conditions in either eye that would preclude the planned treatment or are significant enough to interfere with the interpretation of study endpoints or procedural complications