Yamin Li1, Lina Liang2, Torkel Snellingen3, Kai Xu1, Yun Gao1, Fengmei Zhang4, Chengwei Guo5, Tao Zuo6, Fengming Liang7, Xiaoping Yao8, Xueyan Yang9. 1. Eye Hospital, China Academy of Chinese Medical Sciences, 33 Lugu Road, Shijingshan District, Beijing, 100040, China. 2. Eye Hospital, China Academy of Chinese Medical Sciences, 33 Lugu Road, Shijingshan District, Beijing, 100040, China. lianglina163@163.com. 3. Aurora Eye Research Foundation, St. Olavsgate 4, 3126, Tønsberg, Norway. 4. Henan Province Hospital of Traditional Chinese Medicine/The Second Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, 450002, China. 5. The Affiliated Hospital of Shandong University of Traditional Chinese Medicine /Shandong Province Hospital of Traditional Chinese Medicine, Jinan, 250011, China. 6. The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, 110034, China. 7. The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300110, China. 8. Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, 518033, China. 9. Foshan Hospital of Traditional Chinese Medicine, Foshan, 528500, China.
Abstract
BACKGROUND: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 eightynAMD 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. DISCUSSION: 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. TRIAL REGISTRATION: Chinese Clinical Trial Registry ( http://www.chictr.org.cn ), ChiCTR2000035990 . Registered on 21 August 2020.
RCT Entities:
BACKGROUND: 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 nAMDpatients. 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 nAMDpatients. 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 nAMDpatients 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. DISCUSSION: 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. TRIAL REGISTRATION: Chinese Clinical Trial Registry ( http://www.chictr.org.cn ), ChiCTR2000035990 . Registered on 21 August 2020.
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