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)
ADARx Pharmaceuticals, Inc.
Summary
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.
Eligibility
- Age range
- 60+ years
- Sex
- All
- Healthy volunteers
- No
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 co…
Interventions
- DrugADX-038
siRNA duplex oligonucleotide
- DrugPlacebo
Saline
Locations (24)
- ADARx Clinical SiteGilbert, Arizona
- ADARx Clinical SitePhoenix, Arizona
- ADARx Clinical SiteBeverly Hills, California
- ADARx Clinical SiteHuntington Beach, California
- ADARx Clinical SitePoway, California
- ADARx Clinical SiteOrlando, Florida