Status:
NOT_YET_RECRUITING
Phase 2 Study of ADX-038 in Participants With Geographic Atrophy
Lead Sponsor:
ADARx Pharmaceuticals, Inc.
Conditions:
Geographic Atrophy Secondary to Age-related Macular Degeneration
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief 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 assess...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06990269
Start Date
November 1 2025
End Date
December 1 2027
Last Update
October 7 2025
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