Brolucizumab Shows Promise in Treating Persistent Diabetic Macular Edema
Researchers at Southern Medical University in Guangzhou, China, have conducted a study to evaluate the efficacy and safety of intravitreal brolucizumab 6 mg in Chinese subjects with persistent diabetic macular edema. The study, titled "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," has been published in BMJ Open. The study aims to recruit 52 adult subjects with persistent DME and will follow them for 24 weeks.
Key Takeaways:
- The study focuses on the use of brolucizumab, a new-generation anti-VEGF agent, to treat persistent diabetic macular edema (DME) in Chinese subjects.
- The study aims to evaluate the efficacy and safety of intravitreal brolucizumab 6 mg in patients with persistent DME.
- The primary endpoints of the study will be the proportion of patients with central subfield thickness (CST) reduction and visual acuity improvement.
- The study will be conducted in a single-centre, open-label, single-arm design.
- The study will be funded by the Guangdong Basic And Applied Basic Research Foundation, Guangdong Provincial People's Hospital For Nsfc, National Natural Science Foundation of China, and other organizations.
- The study will recruit 52 adult subjects with persistent DME and will follow them for 24 weeks.
- The study will assess disease activity at week 18 and adjust dosing accordingly.
- The study will be presented at both local and international congresses and the results will be submitted to a peer-reviewed journal.
Statistics:
- 52 adult subjects with persistent DME will be recruited for the study.
- The study will follow subjects for 24 weeks.
- The primary endpoints of the study will be the proportion of patients with central subfield thickness (CST) reduction and visual acuity improvement.
- The study will be funded by multiple organizations, including the Guangdong Basic And Applied Basic Research Foundation and the National Natural Science Foundation of China.
Sources:
- 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, 2025,15(7).
- Jing Li, Guangdong Eye Institute, Department of Ophthalmology, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, People's Republic of China.
- Dan Cao, Honghua Yu, Yunyan Hu, Yijun Hu, Ying Fang, Jiahui Zeng, Anyi Liang, Ziyi Huang, Chenxiao Shen, Huiyi Liao, Chunwen Zheng, Shuyi Ouyang.
- Guangdong Basic And Applied Basic Research Foundation.
- Guangdong Provincial People's Hospital For Nsfc.
- National Natural Science Foundation of China.