Phase 2 Study of ADX-038 in Participants With Geographic Atrophy

A Phase 2, Randomized, Masked, Placebo-Controlled Study of Subcutaneously Administered ADX-038 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Phase 2 study is designed to assess the efficacy of ADX-038 compared with placebo in participants with GA secondary to AMD. Safety, pharmacokinetics (PK), and pharmacodynamics (PD) will also be assessed.

Inclusion Criteria:

• Clinical diagnosis of GA of the macula secondary to AMD
• GA lesions between 2.5 and 12.5 mm2 at screening
• Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol
• Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol

Exclusion Criteria:

• Has GA secondary to causes other than AMD
• Has active ocular disease that compromises or confounds visual function
• History of surgery for retinal detachment
• Has ocular condition other than GA secondary to AMD
• Use of intravitreal complement inhibitors in study eye
• Hereditary or acquired complement deficiency
• Active viral, bacterial or fungal infection
• Liver injury as evidenced by abnormal liver function tests
• Donating blood
• History of choroidal neovascularization in the study eye