Loading clinical trials...

RECRUITINGPHASE2

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)

NCT06990269•ADARx Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (17)

ADARx Clinical Site

Gilbert, Arizona, United States

ADARx Clinical Site

Phoenix, Arizona, United States

ADARx Clinical Site

Beverly Hills, California, United States

ADARx Clinical Site

Huntington Beach, California, United States

ADARx Clinical Site

Poway, California, United States

ADARx Clinical Site

Orlando, Florida, United States

ADARx Clinical Site

Hagerstown, Maryland, United States

ADARx Clinical Site

Erie, Pennsylvania, United States

ADARx Clinical Site

McAllen, Texas, United States

ADARx Clinical Site

Round Rock, Texas, United States

Key Dates

Start Date

November 10, 2025

Primary Completion Date

September 30, 2027

Completion Date

December 1, 2027

Last Updated

March 2, 2026

Enrollment

240

ESTIMATED participants

Conditions

Geographic Atrophy Secondary to Age-related Macular Degeneration

Interventions

ADX-038

DRUG

Placebo

DRUG

Contacts

Nali Castillo

CONTACT

877-232-7974 npak-castillo@adarx.com

Evaluating the Relationship Between Function and Structure in ARCHER II-like Population Using Data From a Natural History Cohort

NCT07424235

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions