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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-10

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Geographic Atrophy Secondary to Age-related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, Masked, Placebo-Controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active - ADX-038

Participants who meet screening eligibility criteria will be randomized to 1 of 2 treatment groups in a 2:1 ratio.

Group Type EXPERIMENTAL

ADX-038

Intervention Type DRUG

siRNA duplex oligonucleotide

Placebo - Saline

Participants who meet screening eligibility criteria will be randomized to 1 of 2 treatment groups in a 2:1 ratio.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline

Interventions

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ADX-038

siRNA duplex oligonucleotide

Intervention Type DRUG

Placebo

Saline

Intervention Type DRUG

Other Intervention Names

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siRNA

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No