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)
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
ADARx Clinical Site
RECRUITING
Gilbert
ADARx Clinical Site
RECRUITING
Phoenix
California
ADARx Clinical Site
RECRUITING
Beverly Hills
ADARx Clinical Site
NOT_YET_RECRUITING
Huntington Beach
ADARx Clinical Site
NOT_YET_RECRUITING
Poway
Florida
ADARx Clinical Site
ENROLLING_BY_INVITATION
Orlando
Maryland
ADARx Clinical Site
RECRUITING
Hagerstown
Pennsylvania
ADARx Clinical Site
RECRUITING
Erie
Texas
ADARx Clinical Site
RECRUITING
Mcallen
ADARx Clinical Site
RECRUITING
Round Rock
ADARx Clinical Site
RECRUITING
San Antonio
ADARx Clinical Site
NOT_YET_RECRUITING
The Woodlands
Other Locations
Australia
ADARx Clinical Site
RECRUITING
Albury
ADARx Clinical Site
RECRUITING
Parramatta
ADARx Clinical Site
RECRUITING
Rowville
Canada
ADARx Clinical Site
RECRUITING
Ottawa
ADARx Clinical Site
RECRUITING
Toronto
Contact Information
Primary
Lisa Melia, MA
lmelia@adarx.com
877-232-7974
Time Frame
Start Date: 2025-11-10
Estimated Completion Date: 2027-12
Participants
Target number of participants: 240
Treatments
Experimental: Active - ADX-038
Participants who meet screening eligibility criteria will be randomized to 1 of 2 treatment groups in a 2:1 ratio.
Placebo_comparator: Placebo - Saline
Participants who meet screening eligibility criteria will be randomized to 1 of 2 treatment groups in a 2:1 ratio.
Related Therapeutic Areas
Sponsors
Leads: ADARx Pharmaceuticals, Inc.