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)

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.

Eligibility

Age range

55+ years

Sex

All

Healthy volunteers

No

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

Locations (28)