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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

Study acronym: BELLAVISTA
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 4 months later Nov 11, 2026 → Apr 2029
See other at-risk trials from Biojiva LLC

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Nov 11, 2026 to Apr 2029 Show 5 more changesShow less
    • Recruitment opened
    • Start date: Jul 7, 2025 to Sep 29, 2026
    • Trial sites expanded: 0 → 17 locations
    • Study completion pushed from Feb 11, 2027 to Apr 2029
    • Eligibility criteria shortened, about 28 words
  2. 2 versions Re-verified since Jun 18, 2025, no change to tracked fieldsv2-v3
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Biojiva LLC
2 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT07029945
Lead Sponsor Biojiva LLC
Conditions
(from sponsor)		 Geographic Atrophy
Related terms Geographic Atrophy, Macular Degeneration
Enrollment 152 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov