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NCT06659445 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Efficacy and Safety of ONL1204 in Patients With GA Associated With AMD
A Phase 2 study of Age-related Macular Degeneration (AMD) and Geographic Atrophy (GA), sponsored by ONL Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 324
- Enrollment target
- 20
- Study locations
NCT06659445: Recruiting Phase 2 study of Age-related Macular Degeneration (AMD) and Geographic Atrophy (GA), sponsored by ONL Therapeutics.
NCT06659445 is a Phase 2 study of Age-related Macular Degeneration (AMD) and Geographic Atrophy (GA) that is actively recruiting participants, run by ONL Therapeutics. The registered enrollment target is 324 participants, below the 101,876-participant average among 7 other Age-related Macular Degeneration (AMD) trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06659445, a Phase 2 study of Age-related Macular Degeneration (AMD) and Geographic Atrophy (GA), is actively recruiting participants, sponsored by ONL Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 324 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
GA lesion area
Conditions Studied
Interventions
- OTHER Sham
- DRUG ONL1204 Opthalmic solution
- DRUG Avacincaptad Pegol intravitreal solution
Study Locations (20)
Arizona
- Associated Retina Consultants - Gilbert
- Associated Retina Consultants - Phoenix
California
- Doheny Image Reading Center - Pasadena
- Bay Area Retina Associates - Walnut Creek
New York
- Retina Associates of Western NY - Rochester
- Long Island Vitreoretinal Consultants - Westbury
South Carolina
- Charleston Neuroscience Institute - Mt. Pleasant
- Palmetto Retina Center - West Columbia
Colorado
- Retina Consultants of Southern Colorado - Colorado Springs
Connecticut
- Retina Group of New England - Waterford
Florida
- Florida Retina Institute - Orlando
Illinois
- Retina Associates, Ltd. - Elmhurst
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 324 participants |
| Start Date | 2025-10-28 |
| Est. Completion | 2028-11 |
| Phase | Phase 2 |
What NCT06659445 shows while recruiting
NCT06659445 is an interventional study that assigns participants to a tested intervention. The registered 324 participants enrollment target is mid-sized for trials with a published cap, below the 101,876-participant average among 7 other Age-related Macular Degeneration (AMD) trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Age-related Macular Degeneration (AMD) appearing as the primary indexed condition, and to 3 interventions - of which Sham is the first listed.
NCT06659445 names 20 study sites across 16 states, led by Arizona, California, New York.
Frequently Asked Questions
What is clinical trial NCT06659445 about?
NCT06659445 is a clinical study titled "Study to Evaluate Efficacy and Safety of ONL1204 in Patients With GA Associated With AMD". 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 di...
What is the current status of trial NCT06659445?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 324 participants. The study started on 2025-10-28. Estimated completion is 2028-11.
What conditions does trial NCT06659445 study?
This clinical trial studies the following conditions: Age-related Macular Degeneration (AMD), Geographic Atrophy (GA).
What interventions are being tested in trial NCT06659445?
The interventions under investigation include: Sham (OTHER), ONL1204 Opthalmic solution (DRUG), Avacincaptad Pegol intravitreal solution (DRUG).
Who is sponsoring clinical trial NCT06659445?
This trial is sponsored by ONL Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06659445 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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