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

Phase 2

Not yet recruiting

• Conditions: Geographic Atrophy Secondary to Age-related Macular Degeneration
• Interventions: Drug: ADX-038; Drug: Placebo

• Registration Number: NCT06990269
• Lead Sponsor: ADARx Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-22
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25
• Study Start: 2025-08
• Primary Completion: 2027-09
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active - ADX-038	ADX-038	Participants who meet screening eligibility criteria will be randomized to 1 of 2 treatment groups in a 2:1 ratio.
Placebo - Saline	Placebo	Participants who meet screening eligibility criteria will be randomized to 1 of 2 treatment groups in a 2:1 ratio.

Primary Outcome Measures

Name	Time	Method
Evaluate the effect of ADX-038 on the preservation of the EZ layer	12 months	Rate of change in the area of total EZ loss in the study eye from baseline to Month 12