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Study to Evaluate Efficacy and Safety of ONL1204 in Patients With GA Associated With AMD
NCT06659445 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06659445
The ClinicalTrials.gov registry entry for NCT06659445 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 324 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ONL Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Geographic Atrophy (GA) appearing as the primary indexed condition, and to 3 interventions — of which Sham is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06659445 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Arizona, California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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: Geographic Atrophy (GA), Age - Related Macular Degeneration (AMD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06659445?
The interventions under investigation include: Sham (OTHER), ONL1204 Opthalmic solution (DRUG), Avacincaptad Pegol intravitreal solution (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06659445?
This trial is sponsored by ONL Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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