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Pre-operative Vabysmo in Patients With Non-clearing Vitreous Hemorrhage Secondary to Proliferative Diabetic Retinopathy

StatusEnrolling by Invitation
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Jan 2025 to Dec 2026 Completion date: Jan 2027 to Jan 2028v5 Show 1 more changeShow less
    • Completion date: Jan 2027 to Jan 2028
  2. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation Start date changed from estimate of Aug 2024 to Jul 12, 2024v4 Show 1 more changeShow less
    • Start date changed from estimate of Aug 2024 to Jul 12, 2024
  3. Notable Start date: Mar 2024 to Aug 2024v3
  4. Notable Start date: Jan 2024 to Mar 2024v2
  5. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In this phase IV, randomized, double-masked, sham-controlled study the investigators hope to determine the efficacy in peri-operative faricimab (Vabysmo) compared to sham in limiting complications from pars plana vitrectomy for diabetic vitreous hemorrhage with or without tractional retinal detachments.
Trial Details
NCT Number NCT06191094
Lead Sponsor University of Colorado, Denver
Conditions Diabetic Retinopathy, Vitreous Hemorrhage Due to Diabetes Mellitus
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov