Actively Recruiting
Phase 2 Randomized Trial of Subcutaneous ADX-038 Treatment Compared to Placebo for Geographic Atrophy from Age-Related Macular Degeneration
Led by ADARx Pharmaceuticals, Inc. · Updated on 2026-07-31
240
Participants Needed
35
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of ADX-038 compared with a placebo in people aged 60 and older who have geographic atrophy GA caused by age-related macular degeneration AMD. This Phase 2 study also aims to assess the safety, how the body processes the drug pharmacokinetics, and how the drug affects the body pharmacodynamics. Participants will be randomly assigned to receive either the active drug ADX-038, which is a siRNA duplex oligonucleotide, or a saline placebo through subcutaneous treatment. The study follows a parallel design with quadruple masking to compare the effects of the treatments over time. During the study, participants will attend clinic visits for various assessments including imaging to evaluate the preservation of the ellipsoid zone EZ layer in the eye over 12 months. The study team will monitor safety and adherence, and participants must complete meningococcal and pneumococcal vaccinations as required. The total study duration extends until 2030, with the primary outcome measured at 12 months.
CONDITIONS
Brief Title
Phase 2 Study of ADX-038 in Participants With Geographic Atrophy
Research Team
N
Nali Castillo
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