Phase 2 Study of ADX-038 in Participants With Geographic Atrophy

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Geographic Atrophy Secondary to Age-related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT06990269

Run by

ADARx Pharmaceuticals, Inc.

People needed

240

Starts

2025-11-10

Expected to finish

2030-08-30

Last updated by the study team

2026-07-31

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ADARx Clinical Site — Sunderland, United Kingdom (enrolling)
• ADARx Clinical Site — Phoenix, Arizona, United States (enrolling)
• ADARx Clinical Site — Bakersfield, California, United States (enrolling)
• ADARx Clinical Site — Beverly Hills, California, United States (enrolling)
• ADARx Clinical Site — Huntington Beach, California, United States (enrolling)
• ADARx Clinical Site — Poway, California, United States (enrolling)
• ADARx Clinical Site — Walnut Creek, California, United States (enrolling)
• ADARx Clinical Site — Orlando, Florida, United States (enrolling)
• ADARx Clinical Site — Wildwood, Florida, United States (enrolling)
• ADARx Clinical Site — Hagerstown, Maryland, United States (enrolling)
• ADARx Clinical Site — Reno, Nevada, United States (enrolling)
• ADARx Clinical Site — Gilbert, Arizona, United States (enrolling)
• ADARx Clinical Site — Austin, Texas, United States (enrolling)
• ADARx Clinical Site — Bellaire, Texas, United States (enrolling)
• ADARx Clinical Site — Dallas, Texas, United States (enrolling)
• ADARx Clinical Site — McAllen, Texas, United States (enrolling)
• ADARx Clinical Site — Round Rock, Texas, United States (enrolling)
• ADARx Clinical Site — San Antonio, Texas, United States (enrolling)
• ADARx Clinical Site — The Woodlands, Texas, United States (enrolling)
• ADARx Clinical Site — St. George, Utah, United States (enrolling)
• ADARx Clinical Site — Albury, New South Wales, Australia (enrolling)
• ADARx Clinical Site — Hurstville, New South Wales, Australia (enrolling)
• ADARx Clinical Site — Parramatta, New South Wales, Australia (enrolling)
• ADARx Clinical Site — East Melbourne, Victoria, Australia (enrolling)
• ADARx Clinical Site — Rowville, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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