๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-11-25

Study to Evaluate ACDN-01 in ABCA4-related Stargardt Retinopathy (STELLAR) (NCT06467344)

ACDN-01-001: Open-Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Subretinal ACDN-01 in Participants With ABCA4-related Retinopathy

๐ŸŸข Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Ascidian Therapeutics, Inc

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

This study is an open-label, single ascending dose clinical trial in participants who have ABCA4-related retinopathies. This is the first-in-human clinical trial in which ACDN-01 will be evaluated for safety, tolerability, and preliminary efficacy following a single subretinal injection of ACDN-01.

Who can join: Review the eligibility criteria below.

Location: University of San Francisco โ€” San Francisco, California

Age range: 12 Years

๐Ÿงช Interventions in This Study

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 (10 Sites)

  • University of San Francisco โ€” San Francisco, California
  • Vitreo Retinal Associates โ€” Gainesville, Florida
  • Bascom Palmer Eye Institute โ€” Miami, Florida
  • Wilmer Eye Institute at John Hopkins โ€” Baltimore, Maryland
  • Massachusetts Eye and Ear โ€” Boston, Massachusetts
  • University of Michigan Kellogg Eye Center โ€” Ann Arbor, Michigan
  • Cincinnati Eye Institute โ€” Cincinnati, Ohio
  • Casey Eye Institute OHSU โ€” Portland, Oregon
  • Retina Foundation of the Southwest โ€” Dallas, Texas
  • Retina Consultants of Texas โ€” Houston, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: (207) 573-0412

Email: researchtrials@ascidian-tx.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†—