Tests ADX-038 injections against placebo for geographic atrophy in older adults
Tests ADX-038 injections against placebo in adults with geographic atrophy from macular degeneration.
Plain-language title generated from the registry record
Registry title: Phase 2 Study of ADX-038 in Participants With Geographic Atrophy
Key facts
- Where
- Milan, Novara, Padova, and Rome, ItalySee the 6 sites
- Phase
- Phase 2
Where in Italy
- ASST Fatebenefratelli SaccoMilan, ItalyNot yet recruiting
- Azienda Socio Sanitaria Territoriale Santi Paolo E CarloMilan, ItalyNot yet recruiting
- Ospedale San Raffaele S.r.l.Milan, ItalyNot yet recruiting
- Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, ItalyNot yet recruiting
- Azienda Ospedaliera di PadovaPadova, ItalyNot yet recruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ADARx Pharmaceuticals, Inc.
- Trial code
- NCT06990269EU 2025-521779-30-00
- Record updated
- 3 September 2026
- Original description
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.Read full original descriptionShow less
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: 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: Use of intravitreal complement inhibitors in study eye; 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; Active viral, bacterial or fungal infection; History of choroidal neovascularization in the study eye; Has GA secondary to causes other than AMD; Hereditary or acquired complement deficiency; Liver injury as evidenced by abnormal liver function tests; Donating blood.