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This Phase 2 study tests ADX-038, a small interfering RNA (siRNA) drug, against placebo in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The main aim is to assess efficacy, with safety, pharmacokinetics and pharmacodynamics also evaluated. Participants must have a clinical diagnosis of GA of the macula secondary to AMD, with GA lesions between 2.5 and 12.5 mm² at screening.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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