RecruitingPhase 2NCT06990269
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)
Sponsor
ADARx Pharmaceuticals, Inc.
Enrollment
240 participants
Start Date
Nov 10, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 60 Years
Inclusion Criteria4
- 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 Criteria10
- 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
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Interventions
DRUGADX-038
siRNA duplex oligonucleotide
DRUGPlacebo
Saline
Locations(24)
View Full Details on ClinicalTrials.gov
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NCT06990269
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