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

Summary

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

Timeline

Start

2024-07-10

Primary completion

2025-07-10

Completion

2025-07-10

Publications

• Huang Z, Hu Y, Shen C, Li J, Liang A, Fang Y, Zeng J, Liao H, Zheng C, Ouyang S, Hu Y, Cao D, Yu H. 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. BMJ Open. 2025 Jul 28;15(7):e099551. doi: 10.1136/bmjopen-2025-099551.

Drugs

Indications