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

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.

NCT Number	NCT07029945
Lead Sponsor	Biojiva LLC
Conditions	Geographic Atrophy
Enrollment	152 participants
Start Date	2025-07-07
Primary Completion	2026-11-11 (estimated)
Study Completion	2027-02-11 (estimated)
Updated on ClinicalTrials.gov	2025-06-26