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Geographic AtrophyVision and hearingDrugPhase 1, Phase 2

What this study is

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.

What's being tested

  • BRX011

    Intervention · DRUG

    Subjects will ingest BRX011 orally, as capsules.

  • Placebo

    Intervention · DRUG

    Subjects will ingest Placebo orally, as capsules.

Study details

Sponsor
Biojiva LLC
Conditions
Geographic Atrophy
Enrolling
152 people
Starts
2026-09-29
Est. completion
2029-04
Design
Triple-blind, randomized, parallel groups, Phase 1, Phase 2
Record
View on ClinicalTrials.gov ↗