Find Stargardt Macular Degeneration Clinical Trials Near You
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)
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:
• 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
• Presence of retinal ganglion cells and/or retinal nerve fiber layer on Spectral Domain Optical Coherence Tomography testing at Screening confirmed by central image reading center
• Adequate organ function and general good health
Locations
United States
California
RayTx Clinical Site
RECRUITING
Bakersfield
Pennsylvania
UPMC Vision Institute
RECRUITING
Pittsburgh
Texas
RayTx Clinical Site
RECRUITING
Bellaire
Contact Information
Primary
Executive Clinical Director
clinicaltrials@raytherapeutics.com
858-617-8610
Time Frame
Start Date:2026-01-28
Estimated Completion Date:2030-12-01
Participants
Target number of participants:18
Treatments
Experimental: Low Dose RTx-021
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.
Experimental: Middle Dose RTx-021
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.
Experimental: High Dose RTx-021
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.