Eye Hospital, China Academy of Chinese Medical Sciences, 33 Lugu Road, Shijingshan District, Beijing, 100040, China.
Aurora Eye Research Foundation, St. Olavsgate 4, 3126, Tønsberg, Norway.
Trials. 2021 Jan 19;22(1):69. doi: 10.1186/s13063-021-05025-x.
Neovascular age-related macular degeneration (nAMD) is the most common cause of irreversible vision loss and blindness among the older people aged 50 and over. Although anti-vascular endothelial growth factor (anti-VEGF) therapies have resulted in improving patient outcomes, there are limitations associated with these treatments. In China, traditional Chinese medicine (TCM) has been used to treat eye diseases for more than 2000 years. Previous studies have shown that TCM may be beneficial for nAMD patients. However, explicit evidence has not been obtained. The purpose of the present trial is to examine the efficacy and safety of the Mingjing granule, a compound Chinese herbal medicine, for nAMD patients.
METHODS/DESIGN: This is a double-blind, placebo-controlled, randomized trial of Mingjing granule as an add-on to intravitreous ranibizumab for nAMD. One hundred eighty nAMD patients from six hospitals in China will be enrolled according to the inclusion and exclusion criteria and randomly allocated into two groups, 90 in each. All participants will receive a 24-week treatment and then be followed up for another 24 weeks. The primary outcome is the mean change of best-corrected visual acuity at week 24 and 48 as compared to the baseline. The secondary outcomes include mean change in central retinal thickness, area of retinal hemorrhage and exudation, and TCM syndrome score, mean number of intravitreal ranibizumab injection, and total cost of the treatment. Indexes of safety include blood regular test, urine regular test, liver function test, renal function test, and electrocardiogram from baseline to weeks 24 and 48. Qualitative control and some standard operating processes will be formed throughout the trial. Any ocular or systemic adverse events will be treated suitably, and related data will be recorded accurately and completely in the case report form.
Based on previous empirical and animal laboratory studies, this study will address the question of whether Mingjing granule could contribute to improving efficacy, safety, and efficiency with need for fewer intravitreal injections of anti-VEGF, improving compliance and visual outcomes in the management of persons with nAMD.
Chinese Clinical Trial Registry ( http://www.chictr.org.cn ), ChiCTR2000035990 . Registered on 21 August 2020.
年龄相关性黄斑变性（AMD）是 50 岁及以上老年人中导致不可逆视力丧失和失明的最常见原因。尽管抗血管内皮生长因子（抗-VEGF）治疗已改善了患者的预后，但这些治疗方法存在局限性。在中国，中医药已用于治疗眼病 2000 多年。先前的研究表明，中医药可能对 nAMD 患者有益。然而，并没有明确的证据。本试验的目的是研究明目颗粒（一种复方中药）对 nAMD 患者的疗效和安全性。
方法/设计：这是一项关于明目颗粒作为 nAMD 玻璃体腔内雷珠单抗辅助治疗的双盲、安慰剂对照、随机试验。根据纳入和排除标准，将来自中国六家医院的 180 名 nAMD 患者纳入研究，并随机分为两组，每组 90 名。所有参与者将接受 24 周的治疗，然后再随访 24 周。主要结局是与基线相比，第 24 周和第 48 周最佳矫正视力的平均变化。次要结局包括中央视网膜厚度、视网膜出血和渗出面积以及中医证候评分的平均变化、玻璃体腔内雷珠单抗注射的平均次数和治疗的总费用。安全性指标包括从基线到第 24 周和第 48 周的血常规、尿常规、肝功能、肾功能和心电图。整个试验过程中将形成定性控制和一些标准操作流程。将适当处理任何眼部或全身不良事件，并在病例报告表中准确、完整地记录相关数据。
基于先前的经验和动物实验室研究，本研究将解决明目颗粒是否有助于提高疗效、安全性和效率，减少玻璃体腔内抗 VEGF 注射次数，提高 nAMD 患者的依从性和视力结局的问题。
中国临床试验注册中心（http://www.chictr.org.cn），ChiCTR2000035990，注册于 2020 年 8 月 21 日。
