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Brolucizumab Efficacy and Safety Single-Arm Descriptive Trial in Patients With Persistent Diabetic Macular Edema

Study acronym: BEST
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 4, 2025 (before its estimated July 10, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary endpoints: 1 to 2v3 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Jul 31, 2025 to Jul 10, 2025
    • Start date: Jul 9, 2024 to Jul 10, 2024
    • Secondary endpoints: 1 to 12
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 5, 2024 to Jul 9, 2024
    • Site details revised
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to evaluate the efficacy of brolucizumab 6 mg in Chinese patients with persistent diabetic macular edema (DME). It will also learn about the safety of brolucizumab 6 mg. The main questions it aims to answer are: Does brolucizumab 6 mg reduce central subfield thickness (CST) and improve best-corrected visual acuity (BCVA) of participants? What medical problems do participants have after receiving intravitreal injections of brolucizumab 6 mg? Researchers will compare baseline CST and BCVA to those at each post-baseline visit to see if brolucizumab 6 mg works to treat persistent DME. Participants will: Receive brolucizumab 6 mg via intravitreal injections following two treatment patterns: Treatment Pattern 1: every 6 weeks for 5 injections Treatment Pattern 2: every 6 weeks for 3 injections followed by 1 injection after 12 weeks Visit the clinic 8 times for treatment and assessments over the course of 28 weeks
Trial Details
NCT Number NCT06498050
Lead Sponsor Guangdong Provincial People's Hospital
Collaborators: Beijing Novartis Pharma
Conditions
(from sponsor)		 Diabetic Macular Edema
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov