NCT06990269

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
52mo left

Started Nov 2025

Longer than P75 for phase_2

Geographic Reach
3 countries

24 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Nov 2025Aug 2030

First Submitted

Initial submission to the registry

May 22, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

November 10, 2025

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2030

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2030

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

4.3 years

First QC Date

May 22, 2025

Last Update Submit

April 20, 2026

Conditions

Geographic Atrophy Secondary to Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

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

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

    12 months

Study Arms (2)

Active - ADX-038

EXPERIMENTAL
Drug: ADX-038

Placebo - Saline

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ADX-038DRUG

siRNA duplex oligonucleotide

Also known as: siRNA
Active - ADX-038
PlaceboDRUG

Saline

Placebo - Saline

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

ADARx Clinical Site

Gilbert, Arizona, 85297, United States

RECRUITING

ADARx Clinical Site

Phoenix, Arizona, 85020, United States

RECRUITING

ADARx Clinical Site

Beverly Hills, California, 90211, United States

RECRUITING

ADARx Clinical Site

Huntington Beach, California, 93647, United States

RECRUITING

ADARx Clinical Site

Poway, California, 92064, United States

RECRUITING

ADARx Clinical Site

Orlando, Florida, 32806, United States

RECRUITING

ADARx Clinical Site

Wildwood, Florida, 34785, United States

RECRUITING

ADARx Clinical Site

Hagerstown, Maryland, 21740, United States

RECRUITING

ADARx Clinical Site

Reno, Nevada, 89502, United States

RECRUITING

ADARx Clinical Site

Erie, Pennsylvania, 16505, United States

RECRUITING

ADARx Clinical Site

Austin, Texas, 78705, United States

RECRUITING

ADARx Clinical Site

Dallas, Texas, 75231, United States

RECRUITING

ADARx Clinical Site

McAllen, Texas, 78503, United States

RECRUITING

ADARx Clinical Site

Round Rock, Texas, 78681, United States

RECRUITING

ADARx Clinical Site

San Antonio, Texas, 78340, United States

RECRUITING

ADARx Clinical Site

The Woodlands, Texas, 77384, United States

RECRUITING

ADARx Clinical Site

St. George, Utah, 84790, United States

RECRUITING

ADARx Clinical Site

Albury, New South Wales, 2640, Australia

RECRUITING

ADARx Clinical Site

Hurstville, New South Wales, 2220, Australia

RECRUITING

ADARx Clinical Site

Parramatta, New South Wales, 2150, Australia

RECRUITING

ADARx Clinical Site

East Melbourne, Victoria, 3002, Australia

RECRUITING

ADARx Clinical Site

Rowville, Victoria, 3178, Australia

RECRUITING

ADARx Clinical Site

Ottawa, Ontario, K2B 7E9, Canada

RECRUITING

ADARx Clinical Site

Toronto, Ontario, M8X 2X3, Canada

RECRUITING

MeSH Terms

Interventions

RNA, Small Interfering

Intervention Hierarchy (Ancestors)

RNA, AntisenseAntisense Elements (Genetics)Nucleic Acids, Nucleotides, and NucleosidesRNANucleic AcidsRNA, Small UntranslatedRNA, Untranslated

Study Officials

  • Donald Fong, MD

    ADARx Pharmaceuticals, Inc.

    STUDY DIRECTOR

Central Study Contacts

Nali Castillo

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, Masked, Placebo-Controlled
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2025

First Posted

May 25, 2025

Study Start

November 10, 2025

Primary Completion (Estimated)

February 28, 2030

Study Completion (Estimated)

August 30, 2030

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations

US(17)CA(2)AU(5)