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.
Age ≥55 years
Visual acuity score of BCVA ≥35 letters using ETDRS charts (≥20/200 Snellen equivalent). A Lower Luminance Deficit of >5 letters.
Clinical diagnosis of GA secondary to AMD. CNV in the fellow eye is permitted.
Clarity of ocular media, adequate pupillary dilation, and fixation to permit the evaluation of the eye, as determined by the investigator
GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like plaquenil maculopathy in either eye.
Any history of documented or active CNV.
Any ocular condition other than GA secondary to AMD that may require surgery or medical intervention during the study period.
Parallel
BRX011
DrugSubjects will ingest BRX011 orally, as capsules.
Placebo
DrugSubjects will ingest Placebo orally, as capsules.
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
Change in low luminance deficit
Change in ETDRS BCVA
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