๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-18

ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD) (NCT06373731)

ReNEW: A Phase 3, Double-Masked, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects Who Have Dry Age-Related Macular Degeneration (Dry AMD)

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Stealth BioTherapeutics Inc.

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

The goal of this clinical trial is to evaluate the efficacy, safety and pharmacokinetics of elamipretide in subjects with dry age-related macular degeneration (AMD). The main questions it aims to answer are: what is the rate of change in the macular area of photoreceptor loss in subjects who receive a daily dose of elamipretide compared with those who receive a look-alike substance that contains no active drug, and what is the safety and tolerability of elamipretide daily subcutaneous injections. Participants will receive either once daily subcutaneous doses of 40mg elamipretide or placebo and the two treatment groups will be compared.

Who can join: Review the eligibility criteria below.

Location: Associated Retina Consultants โ€” Phoenix, Arizona

Age range: 55 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 (53 Sites)

Showing the first 25 of 53 sites.

  • Associated Retina Consultants โ€” Phoenix, Arizona
  • Barnet Dulaney Perkins Eye Center โ€” Sun City, Arizona
  • Retina Associates of Southern California โ€” Huntington Beach, California
  • Retina Consultants of San Diego โ€” Poway, California
  • Retinal Consultants Medical Group โ€” Sacramento, California
  • Orange County Retinal Medical Group โ€” Santa Ana, California
  • Bay Area Retina Associates โ€” Walnut Creek, California
  • Retina Consultants of Southern Colorado โ€” Colorado Springs, Colorado
  • Connecticut Eye Consultants, P.C. โ€” Danbury, Connecticut
  • Vitreo Retinal Associates โ€” Gainesville, Florida
  • Florida Retina Institute โ€” Orlando, Florida
  • Retina Vitreous Associates of Florida โ€” St. Petersburg, Florida
  • University Retina and Macula Associates โ€” Oak Forest, Illinois
  • Associated Vitreoretinal and Uveitis Consultants โ€” Carmel, Indiana
  • Mid Atlantic Retina Specialist โ€” Hagerstown, Maryland
  • Ophthalmic Consultants of Boston โ€” Boston, Massachusetts
  • Kellogg Eye Center โ€” Ann Arbor, Michigan
  • Retina Consultants of Minnesota โ€” Minneapolis, Minnesota
  • Mid Atlantic Retina โ€” Cherry Hill, New Jersey
  • NJ Retina โ€” Teaneck, New Jersey
  • Retina Vitreous Center โ€” Edmond, Oklahoma
  • Retina Northwest, PC โ€” Portland, Oregon
  • Retina Research Institute of Texas โ€” Abilene, Texas
  • Austin Clinical Research, LLC โ€” Austin, Texas
  • Retina Consultants of Texas โ€” Bellaire, Texas

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.

More studies in Age Related Macular Degeneration (ARMD)

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  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†—