Huang Ziyi, Hu Yunyan, Shen Chenxiao, Li Jing, Liang Anyi, Fang Ying, Zeng Jiahui, Liao Huiyi, Zheng Chunwen, Ouyang Shuyi, Hu Yijun, Cao Dan, Yu Honghua
Guangdong Eye Institute, Department of Ophthalmology, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Shantou University Medical College, Shantou, China.
BMJ Open. 2025 Jul 28;15(7):e099551. doi: 10.1136/bmjopen-2025-099551.
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.
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 (DAA) will be arranged at week 18, and if disease activity is detected, subjects will continue with dosing of brolucizumab every 6 weeks (at weeks 18 and 24). Otherwise, the dosing will be adjusted to every 12 weeks (at week 24). The primary endpoints will be the proportion of patients with central subfield thickness (CST) <300 µm and the proportion of patients with ≥5 letters visual improvement at week 28. The secondary endpoints will involve anatomical changes assessed through multimodal imaging techniques containing optical coherence tomography (OCT), OCT angiography (OCTA), ultrawide-field fundus photograph (UWFP), ultrawide-field fluorescein angiography (UWFFA), as well as safety assessment. Additionally, aqueous samples will be collected and cytokine levels will be assessed for exploratory analysis.
This study has been approved by the Ethics Review Committee of Guangdong Provincial People's Hospital (KY2024-319). This study will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with the ICH E6 guidelines for Good Clinical Practice and the applicable regulatory requirements. The study results will be submitted to a peer-reviewed journal and presented at both local and international congresses.
NCT06498050.
持续性糖尿病性黄斑水肿（DME）对传统血管内皮生长因子（VEGF）抑制剂反应不足，已导致严重视力丧失和巨大治疗负担。布罗鲁单抗是一种新一代抗VEGF药物，具有更好的解剖学疗效和更长的作用持续时间。这项单中心、开放标签、单臂设计的临床试验旨在评估玻璃体内注射6mg布罗鲁单抗在中国持续性DME患者中的疗效和安全性。
将从广东省人民医院招募52名患有持续性DME的成年受试者。所有研究眼将每隔6周连续接受3次6mg布罗鲁单抗注射。将在第18周安排疾病活动评估（DAA），如果检测到疾病活动，受试者将继续每6周（在第18周和第24周）注射布罗鲁单抗。否则，给药间隔将调整为每12周（在第24周）。主要终点将是在第28周时中心子野厚度（CST）<300µm的患者比例以及视力提高≥5行的患者比例。次要终点将包括通过多模态成像技术评估的解剖学变化，这些技术包括光学相干断层扫描（OCT）、OCT血管造影（OCTA）、超广角眼底照片（UWFP）、超广角荧光素血管造影（UWFFA），以及安全性评估。此外，将收集房水样本并评估细胞因子水平以进行探索性分析。
本研究已获得广东省人民医院伦理审查委员会批准（KY2024-319）。本研究将按照源自《赫尔辛基宣言》的伦理原则进行，并符合国际人用药品注册技术协调会（ICH）E6《药物临床试验质量管理规范》指南及适用的监管要求。研究结果将提交给同行评审期刊，并在本地和国际会议上展示。
NCT06498050。
