Actively Recruiting
Phase 1/2 Open-Label Dose-Escalation Study to Evaluate Safety of a Single Intravitreal Injection of RTx-021 in Patients With Stargardt Disease
Led by Ray Therapeutics, Inc. · Updated on 2026-04-15
18
Participants Needed
3
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients 16 years of age or older
- Able to comply with the study visit schedule and all protocol assessments
- Diagnosis of Stargardt Disease confirmed by genetic testing
- Study eye and fellow eye best corrected visual acuity meeting study criteria
- Presence of retinal ganglion cells and/or retinal nerve fiber layer confirmed by spectral domain optical coherence tomography
- Adequate organ function and general good health
You will not qualify if you...
- Participation in a clinical study with an investigational drug or therapy in the past 6 months
- Concurrent participation in another interventional ocular clinical study
- Prior receipt of any gene therapy, retinal implant, or ocular cell therapy
- Pre-existing eye conditions that could interfere with treatment or study results
- Known steroid responders with uncontrolled intraocular pressure after steroid use
- Complicating systemic diseases affecting ocular or central nervous system function
- Immunological dysfunction or use of immunosuppressive medications
- Cataract, ocular surgery, or intraocular/peri-ocular injection within 4 months prior to screening
- Prior vitrectomy or aphakia in the study eye
- Known sensitivity to study treatment components or contraindications to peri-procedural medications
- Known contraindication to prophylactic steroid regimen
- Current pregnancy or breastfeeding
- Any condition preventing completion of follow-up examinations during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
RayTx Clinical Site
Bakersfield, California, United States, 93309
Actively Recruiting
2
UPMC Vision Institute
Pittsburgh, Pennsylvania, United States, 15219
Actively Recruiting
3
RayTx Clinical Site
Bellaire, Texas, United States, 77401
Actively Recruiting
Research Team
E
Executive Clinical Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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