Brolucizumab efficacy and safety single-arm descriptive trial in patients with persistent diabetic macular edema (BEST study): protocol for a single-centre, open-label, single-arm clinical trial in China.

ABSTRACT:

Introduction

Persistent diabetic macular edema (DME) with inadequate responsiveness to conventional inhibitors of vascular endothelial growth factor (VEGF) has caused significant vision loss and substantial treatment burdens. Brolucizumab is a new-generation anti-VEGF agent with better anatomical efficacy and prolonged duration of action. This single-centre, open-label, single-arm design clinical trial aims to evaluate the efficacy and safety of intravitreal brolucizumab 6 mg in Chinese subjects with persistent DME.

Methods and analysis

A total of 52 adult subjects with persistent DME will be recruited from Guangdong Provincial People's Hospital. All study eyes will receive three consecutive 6 mg brolucizumab injections at intervals of 6 weeks. Disease activity assessment (D

SUBMITTER: Huang Z 

PROVIDER: S-EPMC12306264 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature