Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Phase 1/2 Study of the Safety and Efficacy of BRX011 Oral Administration Once Daily in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Sponsor: Biojiva LLC
Summary
This study aims to evaluate the safety and efficacy of BRX011, an oral medication, taken once daily by participants with geographic atrophy secondary to age-related macular degeneration. The study is conducted in phases 1 and 2, focusing on assessing both safety (tolerability) and effectiveness (efficacy) of the treatment. Participants: Adults with geographic atrophy due to age-related macular degeneration. Treatment: BRX011 or Placebo is taken once daily as per the protocol. Duration: The study involves multiple visits over 96 weeks to monitor participants' health and response to treatment. Safety Monitoring: Regular checks for adverse events and health status to ensure participant well-being. Checks will include examination of vital signs, clinical labs, ocular exams, and ocular imaging. Primary Outcome Measure: Efficacy of BRX011 in the annual rate of change in the square root of GA area, as specified in the protocol.
Key Details
Gender
All
Age Range
55 Years - Any
Study Type
INTERVENTIONAL
Enrollment
152
Start Date
2026-09-29
Completion Date
2029-04
Last Updated
2026-09-23
Healthy Volunteers
No
Conditions
Interventions
BRX011
Subjects will ingest BRX011 orally, as capsules.
Placebo
Subjects will ingest Placebo orally, as capsules.
Locations (17)
Associated Retina Consultants - PHX
Gilbert, Arizona, United States
Associated Retina Consultants
Phoenix, Arizona, United States
Retina Specialists of Mississippi - Hattiesburg
Hattiesburg, Mississippi, United States
Sierra Eye Associates
Reno, Nevada, United States
Retina Associates of Cleveland - Beachwood
Beachwood, Ohio, United States
Retina Associates of Cleveland
Cleveland, Ohio, United States
Retina Associates of Cleveland - Middleburg Heights
Middleburg Heights, Ohio, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Valley Retina Institute, PA
McAllen, Texas, United States
Retina Research Center of Southern Utah
St. George, Utah, United States
Spokane Eye Clinic
Spokane, Washington, United States
Eye Clinic Albury Wodonga
Albury, New South Wales, Australia
Nexus Eye Care
Baulkham Hills, New South Wales, Australia
Retina & Macula Specialists
Hurstville, New South Wales, Australia
Sydney Eye Hospital
Sydney, New South Wales, Australia
Centre for Eye Research Australia (CERA)
East Melbourne, Victoria, Australia
Retina Specialists Victoria
Rowville, Victoria, Australia