NCT07029945

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Biojiva LLC · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Geographic Atrophy

Interventions

Type	Name	Description
DRUG	BRX011	Subjects will ingest BRX011 orally, as capsules.
DRUG	Placebo	Subjects will ingest Placebo orally, as capsules.

Timeline

• Start date: 2025-07-07
• Primary completion: 2026-11-11
• Completion: 2027-02-11
• First posted: 2025-06-19
• Last updated: 2025-06-26

Regulatory

• FDA-regulated drug study