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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
152
Subjects will ingest BRX011 orally, as capsules.
Subjects will ingest Placebo orally, as capsules.
Associated Retina Consultants - PHX
Gilbert, Arizona, United States
RECRUITINGAssociated Retina Consultants
Phoenix, Arizona, United States
RECRUITINGRetina Specialists of Mississippi - Hattiesburg
Hattiesburg, Mississippi, United States
NOT_YET_RECRUITINGSierra Eye Associates
Reno, Nevada, United States
NOT_YET_RECRUITINGRetina Associates of Cleveland - Beachwood
Beachwood, Ohio, United States
RECRUITINGRetina Associates of Cleveland
Cleveland, Ohio, United States
NOT_YET_RECRUITINGRetina Associates of Cleveland - Middleburg Heights
Middleburg Heights, Ohio, United States
NOT_YET_RECRUITINGRetina Research Institute of Texas
Abilene, Texas, United States
RECRUITINGValley Retina Institute, PA
McAllen, Texas, United States
RECRUITINGRetina Research Center of Southern Utah
St. George, Utah, United States
NOT_YET_RECRUITING...and 7 more locations
Annual rate of change in the square root of GA area
Annual rate of change in the square root of GA area assessed by FAF
Time frame: Baseline (Day 0) to Week 96
Change in low luminance deficit
Time frame: Baseline (Day 0) to Week 96
Change in ETDRS BCVA
Time frame: Baseline (Day 0) to Week 96
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