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

NCT06659445 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2025-12-05

No results posted yet for this 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

  • Geographic Atrophy (GA)
  • Age - Related Macular Degeneration (AMD)

Interventions

DRUG

ONL1204 Opthalmic solution

Liquid formulation ONL1204 Ophthalmic Solution administered by intravitreal (IVT) injection

DRUG

Avacincaptad Pegol intravitreal solution

Liquid formulation Avacincaptad Pegol administered by intravitreal (IVT) injection

OTHER

Sham

Sham injection

Sponsors & Collaborators

  • ONL Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-28
Primary Completion
2028-11-30
Completion
2028-11-30
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06659445 on ClinicalTrials.gov