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NCT06990269PHASE2Recruiting

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

ADARx Pharmaceuticals, Inc.

Start Date

11/10/2025

Completion Date

8/30/2030

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 Criteria

Age Range: 60 years to No maximum

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 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

Interventions

DRUG

ADX-038

DRUG

Placebo

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Conditions

Geographic Atrophy Secondary to Age-related Macular Degeneration

Locations

ADARx Clinical Site

Gilbert, Arizona 85297

United States

ADARx Clinical Site

Phoenix, Arizona 85020

United States

ADARx Clinical Site

Bakersfield, California 93309

United States

ADARx Clinical Site

Beverly Hills, California 90211

United States

ADARx Clinical Site

Huntington Beach, California 93647

United States

ADARx Clinical Site

Poway, California 92064

United States

ADARx Clinical Site

Walnut Creek, California 94598

United States

ADARx Clinical Site

Orlando, Florida 32806

United States

ADARx Clinical Site

Wildwood, Florida 34785

United States

ADARx Clinical Site

Hagerstown, Maryland 21740

United States

ADARx Clinical Site

Reno, Nevada 89502

United States

ADARx Clinical Site

Erie, Pennsylvania 16505

United States

ADARx Clinical Site

Austin, Texas 78705

United States

ADARx Clinical Site

Bellaire, Texas 77401

United States

ADARx Clinical Site

Dallas, Texas 75231

United States

ADARx Clinical Site

McAllen, Texas 78503

United States

ADARx Clinical Site

Round Rock, Texas 78681

United States

ADARx Clinical Site

San Antonio, Texas 78340

United States

ADARx Clinical Site

The Woodlands, Texas 77384

United States

ADARx Clinical Site

St. George, Utah 84790

United States

ADARx Clinical Site

Albury, New South Wales 2640

Australia

ADARx Clinical Site

Hurstville, New South Wales 2220

Australia

ADARx Clinical Site

Parramatta, New South Wales 2150

Australia

ADARx Clinical Site

East Melbourne, Victoria 3002

Australia

ADARx Clinical Site

Rowville, Victoria 3178

Australia

ADARx Clinical Site

Malvern, VIC 3144

Australia

ADARx Clinical Site

Sydney, NWS 2000

Australia

ADARx Clinical Site

Vancouver, British Columbia V5Z 1M9

Canada

ADARx Clinical Site

Vancouver, British Columbia

Canada

ADARx Clinical Site

Ottawa, Ontario K2B 7E9

Canada

ADARx Clinical Site

Toronto, Ontario M3C 0G9

Canada

ADARx Clinical Site

Toronto, Ontario M8X 2X3

Canada

ADARx Clinical Site

Liverpool, BC L7 8XP

United Kingdom

ADARx Clinical Site

London, NW10 7NS

United Kingdom

ADARx Clinical Site

Sunderland, SR1 3AE

United Kingdom