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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

55 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ONL1204 Opthalmic solution — DRUG
  Liquid formulation ONL1204 Ophthalmic Solution administered by intravitreal (IVT) injection
• Avacincaptad Pegol intravitreal solution — DRUG
  Liquid formulation Avacincaptad Pegol administered by intravitreal (IVT) injection
• Sham — OTHER
  Sham injection

Study Details

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.

Key Dates

Start date

Oct 28, 2025

Status verified

Dec 2025

Primary completion

Nov 30, 2028

Completion

Nov 30, 2028

Study Design

Enrollment

324 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: ONL1204 Opthalmic solution (1 of 6 Treatment Groups) administered by intravitreal injection
  ONL1204 100 µg administered by intravitreal (IVT) injection every 12 weeks
• Active Comparator: ONL1204 Opthalmic solution (2 of 6 Treatment Groups) administered by intravitreal injection
  ONL1204 200 µg administered by intravitreal (IVT) injection every 12 weeks
• Experimental: ONL1204 Opthalmic solution (3 of 6 Treatment Groups) administered by intravitreal injection
  ONL1204 200 µg administered by intravitreal (IVT) injection every 24 weeks
• Sham Comparator: Sham Comparator (4 of 6 Treatment Groups)
  Sham injection every 12 weeks
• Sham Comparator: Sham Comparator (5 of 6 Treatment Groups)
  Sham injection every 24 weeks
• Active Comparator: Avacincaptad pegol intravitreal solution (6 of 6 Treatment Groups - US ONLY)
  Avacincaptad pegol administered by intravitreal (IVT) injection - (2 mg (0.1 mL of 20 mg/mL solution) once monthly

Primary Outcome Measure

Primary Endpoint [ Time Frame: From enrollment to the end of treatment at 48 weeks. ]

Central Contacts

• Study Coordinator
  734-412-8787
  [email protected]

Locations (27)

Find similar trials in Gilbert, AZ

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