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
Start Date
9/29/2026
Completion Date
4/1/2029
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.
Eligibility Criteria
Age Range: 55 years to No maximum
Interventions
BRX011
Placebo
Conditions
Locations
Associated Retina Consultants - PHX
Gilbert, Arizona 85020
United States
Associated Retina Consultants
Phoenix, Arizona 85020
United States
Retina Specialists of Mississippi - Hattiesburg
Hattiesburg, Mississippi 39402
United States
Sierra Eye Associates
Reno, Nevada 89502
United States
Retina Associates of Cleveland - Beachwood
Beachwood, Ohio 44122
United States
Retina Associates of Cleveland
Cleveland, Ohio 44121
United States
Retina Associates of Cleveland - Middleburg Heights
Middleburg Heights, Ohio 44130
United States
Retina Research Institute of Texas
Abilene, Texas 79606
United States
Valley Retina Institute, PA
McAllen, Texas 78503
United States
Retina Research Center of Southern Utah
St. George, Utah 84790
United States
Spokane Eye Clinic
Spokane, Washington 99204
United States
Eye Clinic Albury Wodonga
Albury, New South Wales 2640
Australia
Nexus Eye Care
Baulkham Hills, New South Wales 2153
Australia
Retina & Macula Specialists
Hurstville, New South Wales 2220
Australia
Sydney Eye Hospital
Sydney, New South Wales 2000
Australia
Centre for Eye Research Australia (CERA)
East Melbourne, Victoria 3002
Australia
Retina Specialists Victoria
Rowville, Victoria 3178
Australia