๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-04-13

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, Open-Label, Dose-Escalation Study to Evaluate Safety of a Single Intravitreal Injection of RTx-021 in Patients With Stargardt Disease (AURORA)

๐ŸŸข Recruiting Phase1 / Phase2 ๐Ÿ“‹ Clinical Research Protocol Sponsor: Ray Therapeutics, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: RayTx Clinical Site โ€” Bakersfield, California

Age range: 16 Years

๐Ÿงช Interventions in This Study

  • RTx-021 (GENETIC)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (3 Sites)

  • RayTx Clinical Site โ€” Bakersfield, California
  • UPMC Vision Institute โ€” Pittsburgh, Pennsylvania
  • RayTx Clinical Site โ€” Bellaire, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: (858) 617-8610

Email: clinicaltrials@raytherapeutics.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—