๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-25

Study to Evaluate Efficacy and Safety of ONL1204 in Patients With GA Associated With AMD (NCT06659445)

A Phase 2 Multicenter, Randomized, Double-masked, Sham-controlled, Reference-arm Study to Evaluate Efficacy and Safety of ONL1204 in Patients With Geographic Atrophy (GA) Associated With Age-related Macular Degeneration (AMD)

๐ŸŸข Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: ONL Therapeutics

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

The purpose of this study is to collect efficacy and safety information of intravitreal injection for 3 experimental arms, including 2 dose levels of ONL1204 and 2 treatment frequencies in patients with GA associated with AMD. GA associated with AMD is one of the world's leading causes of visual disability and legal blindness globally. Associated with aging, cigarette smoking, obesity, diets low in certain nutrients, a lifestyle related to cardiac risk, and a growing list of genetic factors, AMD is becoming an increasingly prevalent public health concern, especially as the global population ages. ONL1204 is a first-in-class inhibitor of fragment apoptosis stimulator receptor-mediated cell death that has demonstrated protection of multiple retinal cell types in numerous preclinical models of retinal disease, including models of dry AMD.

Who can join: Review the eligibility criteria below.

Location: Associated Retina Consultants โ€” Gilbert, Arizona

Age range: 55 Years

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 (117 Sites)

Showing the first 25 of 117 sites.

  • Associated Retina Consultants โ€” Gilbert, Arizona
  • Associated Retina Consultants โ€” Phoenix, Arizona
  • California Retina Consultants โ€” Bakersfield, California
  • Retina-Vitreous Associates Medical Group โ€” Beverly Hills, California
  • Macula and Retina Institute โ€” Glendale, California
  • Salehi Retina Institute, dba Retina Associates of Southern California โ€” Huntington Beach, California
  • Desert Retina Consultants โ€” Palm Desert, California
  • Retinal Consultants Medical Group โ€” Sacramento, California
  • Bay Area Retina Associates โ€” Walnut Creek, California
  • Retina Consultants of Southern Colorado โ€” Colorado Springs, Colorado
  • Retina Group of New England โ€” Waterford, Connecticut
  • Florida Retina Institute โ€” Orlando, Florida
  • Retina Specialty Institute โ€” Pensacola, Florida
  • Retina Group of Florida โ€” Sarasota, Florida
  • Retina Associates of Florida, LLC โ€” Tampa, Florida
  • Northwestern Medical Group โ€” Chicago, Illinois
  • The University of Chicago Medicine Duchossois Center for Advanced Medicine โ€” Chicago, Illinois
  • Retina Associates, Ltd. โ€” Elmhurst, Illinois
  • Illinois Retina Associates, S.C. โ€” Oak Park, Illinois
  • Retina Partners Midwest, P.C. โ€” Carmel, Indiana
  • Retina Specialists โ€” Towson, Maryland
  • Retina Research Institute at New England Retina Consultants โ€” Springfield, Massachusetts
  • University of Michigan Kellogg Eye Center โ€” Ann Arbor, Michigan
  • Associated Retinal Consultants, P.C. โ€” Royal Oak, Michigan
  • Associated Retinal Consultants, P.C. โ€” Traverse City, Michigan

๐Ÿ“ž Contact the Study Coordinator

Phone: (734) 412-8787

Email: info@onltherapeutics.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.

More studies in Geographic Atrophy (GA)

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†—