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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Geographic Atrophy Secondary to Age-related Macular Degeneration

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ADARx Clinical Site, Albury, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADX-038

Drug

siRNA duplex oligonucleotide

Other names: siRNA

Placebo

Drug

Saline

Primary outcomes

Evaluate the effect of ADX-038 on the preservation of the EZ layer

Time frame: 12 months

Rate of change in the area of total EZ loss in the study eye from baseline to Month 12

Study contacts

Contact information is provided by the study sponsor or research team.

Nali Castillo

CONTACT

[email protected]

877-232-7974

Sponsors and collaborators

Lead sponsor

ADARx Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start: 2025
Primary completion: 2030
Study completion: 2030
First posted: May 25, 2025
Registry last updated: Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting