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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

Interested in This Trial?

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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

Riverside, California 92505

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

Sutherland, New South Wales 2232

Australia

ADARx Clinical Site

Sydney, New South Wales 2000

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

Graz, Styria 8036

Austria

ADARx Clinical Site

Innsbruck, Tyrol 6020

Austria

ADARx Clinical Site

Vienna, 1090

Austria

ADARx Clinical Site

Vienna, 1140

Austria

ADARx Clinical Site

Edmonton, Alberta T5H 0X5

Canada

ADARx Clinical Site

Vancouver, British Columbia V5Z 1M9

Canada

ADARx Clinical Site

Vancouver, British Columbia

Canada

ADARx Clinical Site

London, Ontario N6A4V2

Canada

ADARx Clinical Site

Ottawa, Ontario K1H 8L6

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

Prague, 100 34

Czechia

ADARx Clinical Site

Prague, 140 00

Czechia

ADARx Clinical Site

Praha Klanovice, 12808

Czechia

ADARx Clinical Site

Bonn, North Rhine-Westphalia 53127

Germany

ADARx Clinical Site

Sulzbach, Saarland 66280

Germany

ADARx Clinical Site

Cologne, 50937

Germany

ADARx Clinical Site

Giessen, 35392

Germany

ADARx Clinical Site

Mainz, 55122

Germany

ADARx Clinical Site

München, 80336

Germany

ADARx Clinical Site

Münster, 48149

Germany

ADARx Clinical Site

Tübingen, 72076

Germany

ADARx Clinical Site

Pécs, Baranya 7621

Hungary

ADARx Clinical Site

Budapest, 1085

Hungary

ADARx Clinical Site

Budapest, 1106

Hungary

ADARx Clinical Site

Budapest, 1133

Hungary

ADARx Clinical Site

Debrecen, 4032

Hungary

ADARx Clinical Site

Milan, MI 20132

Italy

ADARx Clinical Site

Roma, RM 00168

Italy

ADARx Clinical Site

Milan, 20121

Italy

ADARx Clinical Site

Milan, 20122

Italy

ADARx Clinical Site

Milan, 20142

Italy

ADARx Clinical Site

Novara, 28100

Italy

ADARx Clinical Site

Padova, 35128

Italy

ADARx Clinical Site

Coimbra, 3000-548

Portugal

ADARx Clinical Site

Coimbra, 3004-561

Portugal

ADARx Clinical Site

Coimbra, 3030-163

Portugal

ADARx Clinical Site

Porto, 4200-319

Portugal

ADARx Clinical Site

Barcelona, 08022

Spain

ADARx Clinical Site

Barcelona, 08035

Spain

ADARx Clinical Site

Barcelona, 08908

Spain

ADARx Clinical Site

Madrid, 28040

Spain

ADARx Clinical Site

Valencia, 46004

Spain

ADARx Clinical Site

Olten, Canton of Solothurn 4600

Switzerland

ADARx Clinical Site

Basel, 4031

Switzerland

ADARx Clinical Site

Bern, 3010

Switzerland

ADARx Clinical Site

Liverpool, BC L7 8XP

United Kingdom

ADARx Clinical Site

Dorchester, Dorset DT1 2JY

United Kingdom

ADARx Clinical Site

Wolverhampton, West Midlands WV10 0QP

United Kingdom

ADARx Clinical Site

London, NW10 7NS

United Kingdom

ADARx Clinical Site

London, SW17 0QT

United Kingdom

ADARx Clinical Site

Sunderland, SR1 3AE

United Kingdom