Study to Evaluate Efficacy and Safety of ONL1204 in Patients With GA Associated With AMD
Public ClinicalTrials.gov record NCT06659445. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06659445
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 324 participants
Conditions and interventions
Interventions
- ONL1204 Opthalmic solution Drug
- Avacincaptad Pegol intravitreal solution Drug
- Sham Other
Drug · Other
Eligibility (public fields only)
- Age range
- 55 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 27, 2025
- Primary completion
- Oct 31, 2028
- Completion
- Oct 31, 2028
- Last update posted
- Aug 25, 2026
2025 – 2028
United States locations
- U.S. sites
- 53
- U.S. states
- 22
- U.S. cities
- 51
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Associated Retina Consultants | Gilbert | Arizona | 85297 | Recruiting |
| Associated Retina Consultants | Phoenix | Arizona | 85020 | Recruiting |
| California Retina Consultants | Bakersfield | California | 93309 | Recruiting |
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | Recruiting |
| Macula and Retina Institute | Glendale | California | 91203 | Recruiting |
| Salehi Retina Institute, dba Retina Associates of Southern California | Huntington Beach | California | 92647 | Recruiting |
| Desert Retina Consultants | Palm Desert | California | 92211 | Recruiting |
| Retinal Consultants Medical Group | Sacramento | California | 95841 | Recruiting |
| Bay Area Retina Associates | Walnut Creek | California | 94598 | Recruiting |
| Retina Consultants of Southern Colorado | Colorado Springs | Colorado | 80909-1183 | Recruiting |
| Retina Group of New England | Waterford | Connecticut | 06385 | Recruiting |
| Florida Retina Institute | Orlando | Florida | 32806 | Recruiting |
| Retina Specialty Institute | Pensacola | Florida | 32503 | Recruiting |
| Retina Group of Florida | Sarasota | Florida | 34232 | Recruiting |
| Retina Associates of Florida, LLC | Tampa | Florida | 33609-4614 | Recruiting |
| Northwestern Medical Group | Chicago | Illinois | 60611 | Recruiting |
| The University of Chicago Medicine Duchossois Center for Advanced Medicine | Chicago | Illinois | 60637 | Recruiting |
| Retina Associates, Ltd. | Elmhurst | Illinois | 60126 | Recruiting |
| Illinois Retina Associates, S.C. | Oak Park | Illinois | 60304 | Recruiting |
| Retina Partners Midwest, P.C. | Carmel | Indiana | 46032 | Recruiting |
| Retina Specialists | Towson | Maryland | 21204 | Recruiting |
| Retina Research Institute at New England Retina Consultants | Springfield | Massachusetts | 01107 | Recruiting |
| University of Michigan Kellogg Eye Center | Ann Arbor | Michigan | 48105 | Recruiting |
| Associated Retinal Consultants, P.C. | Royal Oak | Michigan | 48073 | Recruiting |
| Associated Retinal Consultants, P.C. | Traverse City | Michigan | 49686 | Recruiting |
| Mayo Clinic | Rochester | Minnesota | 55905 | Recruiting |
| The Retina Institute | St Louis | Missouri | 63128 | Recruiting |
| Sierra Eye Associates | Reno | Nevada | 89502 | Recruiting |
| Retina Vitreous Surgeons of CNY, PC | Liverpool | New York | 13088 | Recruiting |
| Ophthalmic Consultants of Long Island | Oceanside | New York | 11572 | Recruiting |
| Retina Associates of Western NY | Rochester | New York | 14620 | Recruiting |
| Long Island Vitreoretinal Consultants | Westbury | New York | 11590 | Recruiting |
| North Carolina Retina Associates | Cary | North Carolina | 27511 | Recruiting |
| Duke Eye Center | Durham | North Carolina | 27710 | Recruiting |
| North Carolina Retina Associates | Greenville | North Carolina | 27834 | Recruiting |
| North Carolina Retina Associates, S.C. | Wake Forest | North Carolina | 27587 | Recruiting |
| Cleveland Clinic Foundation-Cole Eye Institute | Cleveland | Ohio | 44195 | Recruiting |
| Erie Retina Research, LLC (Clinic) | Erie | Pennsylvania | 16505 | Recruiting |
| Charleston Neuroscience Institute | Mt. Pleasant | South Carolina | 29464 | Recruiting |
| Palmetto Retina Center | West Columbia | South Carolina | 29169 | Recruiting |
| Vanderbilt Eye Institute | Nashville | Tennessee | 37232 | Recruiting |
| Austin Retina Associates | Austin | Texas | 78705 | Recruiting |
| Retina Consultants of Texas | Beaumont | Texas | 77707 | Recruiting |
| Retina Consultants of Texas | Bellaire | Texas | 77401 | Recruiting |
| Retina Consultants of Texas | Katy | Texas | 77494 | Recruiting |
| Valley Retina Institute, P.A. | McAllen | Texas | 78503 | Recruiting |
| Retina Associates of South Texas, PA | San Antonio | Texas | 78240 | Recruiting |
| Retina Consultants of Texas | San Antonio | Texas | 78240 | Recruiting |
| Retina Center of Texas | Southlake | Texas | 76092 | Recruiting |
| Retina Consultants of Texas | The Woodlands | Texas | 77384 | Recruiting |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | Recruiting |
| Pacific Northwest Retina | Bellevue | Washington | 98004 | Recruiting |
| Pacific Northwest Retina, PLLC | Silverdale | Washington | 98383 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 64 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06659445, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 25, 2026 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06659445 live on ClinicalTrials.gov.