Study of ALK-001 on the Progression of Stargardt Disease (NCT07419334)
A Phase 3 Multicenter, Double-Masked, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Efficacy of Gildeuretinol Acetate (ALK 001) on the Progression of Stargardt Disease (STGD)
🩺 Plain-English Summary (8th-Grade Level)
This study evaluates the efficacy and safety of investigational study drug ALK-001 in participants 8 to 45 years of age, inclusive, with symptoms and signs of autosomal recessive Stargardt disease (STGD)
Who can join: Review the eligibility criteria below.
Location: Associated Retina Consultants — Phoenix, Arizona
Age range: 8 Years to 45 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (10 Sites)
- Associated Retina Consultants — Phoenix, Arizona
- University of Colorado SOM, Sue-Anschutz-Rodgers Eye Center — Aurora, Colorado
- Vitreo Retinal Associates — Gainesville, Florida
- Foundation for Vision Research — Grand Rapids, Michigan
- Ohio State Havener Eye Institute — Columbus, Ohio
- Erie Retina Research — Erie, Pennsylvania
- Retina Foundation of the Southwest — Dallas, Texas
- Star Retina — Fort Worth, Texas
- Medical Center Ophthalmology Associates — San Antonio, Texas
- The Retina Group of Washington — Fairfax, Virginia
📞 Contact the Study Coordinator
Phone: (877) 255-7476
Email: trials@alkeuspharma.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Stargardt Disease
- An Observational Study in Children and Adults With Stargardt Disease — Dallas, Texas
- Non-interventional Long Term Follow-up Study of Participants Previously Enrolled in the STARLIGHT Study — Miami, Florida
- Open-Label Extension: Tolerability and Effects of ALK-001 on Stargardt Disease (TEASE) — Phoenix, Arizona
- A Phase 2/3 Trial to Assess the Efficacy and Safety of OCU410ST for Stargardt Disease — Phoenix, Arizona
- Phase 1/2 Open-Label Dose-Escalation Study to Evaluate Safety of a Single Intravitreal Injection of RTx-021 in Patients With Stargardt Disease — Bakersfield, California
- Study to Evaluate ACDN-01 in ABCA4-related Stargardt Retinopathy (STELLAR) — San Francisco, California
Explore by condition: All Stargardt Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.