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

• Status: NOT_YET_RECRUITING
• Trial end date: 2027-02-11

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.

• Phase: PHASE1

Details

• Lead Sponsor: Biojiva LLC