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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized, Masked, Placebo-Controlled
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active - ADX-038
  • Drug: ADX-038
    siRNA duplex oligonucleotide
    Other names:
    • siRNA
Placebo Comparator
Placebo - Saline
  • Drug: Placebo
    Saline

Recruiting Locations

ADARx Clinical Site
Gilbert, Arizona 85297

ADARx Clinical Site
Phoenix, Arizona 85020

ADARx Clinical Site
Bakersfield, California 93309

ADARx Clinical Site
Beverly Hills, California 90211

ADARx Clinical Site
Huntington Beach, California 93647

ADARx Clinical Site
Poway, California 92064

ADARx Clinical Site
Walnut Creek, California 94598

ADARx Clinical Site
Orlando, Florida 32806

ADARx Clinical Site
Wildwood, Florida 34785

ADARx Clinical Site
Hagerstown, Maryland 21740

ADARx Clinical Site
Reno, Nevada 89502

ADARx Clinical Site
Austin, Texas 78705

ADARx Clinical Site
Bellaire, Texas 77401

ADARx Clinical Site
Dallas, Texas 75231

ADARx Clinical Site
McAllen, Texas 78503

ADARx Clinical Site
Round Rock, Texas 78681

ADARx Clinical Site
San Antonio, Texas 78340

ADARx Clinical Site
The Woodlands, Texas 77384

ADARx Clinical Site
St. George, Utah 84790

More Details

Status
Recruiting
Sponsor
ADARx Pharmaceuticals, Inc.

Study Contact

Nali Castillo
877-232-7974
info@adarx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.