Intravitreal conbercept for diabetic macular oedema: 2-year results from a randomised controlled trial and open-label extension study

doi:10.1136/bjophthalmol-2020-318690

科研成果详情

题名	Intravitreal conbercept for diabetic macular oedema: 2-year results from a randomised controlled trial and open-label extension study
作者	Liu, Kun 1,2; Wang, Hanying 1,2; He, Wei 3; Ye, Jian 4; Song, Yanping 5; Wang, Yusheng 6,7; Liu, Xiaoling8; Wu, Zhifeng 9; Chen, Shaojun 10; Fan, Ke 11; Liu, Yuling 12; Zhang, Feng 13,14; Li, Zhiqing 15; Liu, Lin 16; Zhang, Junjun 17; Zhang, Xuedong 18; Ye, Junjie 19; Liang, Xiaoling 20; Li, Xiaoxin 21; Ke, Xiao 22; Wu, Quan 22; Li, Jie 23; Tao, Shanshan 23; Wang, Xinguo 22; Rosenfeld, Philip 24; Heier, Jeffrey S 25; Kaiser, Peter 26; Xu, Xun 1,2
发表日期	2022-10
发表期刊	BRITISH JOURNAL OF OPHTHALMOLOGY 影响因子和分区
语种	英语
原始文献类型	Article ; Early Access
关键词	clinical trial macula retina treatment lasers.
其他关键词	VEGF ; AFLIBERCEPT ; RANIBIZUMAB ; PREVALENCE ; INJECTIONS ; OUTCOMES
摘要	Background To demonstrate the efficacy and safety of intravitreal injections of conbercept versus laser photocoagulation in the treatment of diabetic macular oedema (DME). Methods A 12-month multicentre, randomised, double-masked, double-sham, parallel controlled, phase Ill trial (Sailing Study), followed by a 12-month open-label extension study. Patients with centreinvolved DME were randomly assigned to receive either laser photocoagulation followed by pro re nata (PRN) sham intravitreal injections (laser/sham) or sham laser photocoagulation followed by PRN 0.5 mg conbercept intravitreal injections (sham/conbercept). Patients who entered the extension study received PRN conbercept treatment. The primary endpoint was the changes in best-corrected visual acuity (BCVA) from baseline. Results A total of 248 eyes were included in the full analysis set and 157 eyes continued in the extension study. Significant improvement in mean change in BCVA from baseline to month 12 was observed in the sham/conbercept group (8.2 +/- 9.5 letters), whereas no improvement was observed in the laser/sham group (0.3 +/- 12.0 letters). Patients in the laser/sham group showed a marked improvement in BCVA after the switch to conbercept in the extension study, and there was no difference in BCVA between the two groups at the end of the extension study. Conclusion The use of a conbercept PRN intravitreal injection regimen improved the BCVA of patients with DME, and its efficacy was better than that of laser photocoagulations, and the same efficacy was observed when the eyes treated with laser alone were switched to conbercept.
资助项目	National Key R&D Program of China [2016YFC0904800, 2019YFC0840607]; Chengdu Kanghong Biotechnology Inc. (ShuxiRoad, JinniuDistrict, Chengdu, China)
出版者	BMJ PUBLISHING GROUP
出版地	LONDON
ISSN	0007-1161
EISSN	1468-2079
卷号	106 期号:10 页码:1436-1443
DOI	10.1136/bjophthalmol-2020-318690
页数	8
WOS类目	Ophthalmology
WOS研究方向	Ophthalmology
WOS记录号	WOS:000727738200001
收录类别	SCIE ; PUBMED ; SCOPUS
URL	查看原文
PubMed ID	34001667
SCOPUSEID	2-s2.0-85106154036
通讯作者地址	[Xu, Xun]Department of Ophthalmology (Aka National Clinical Research Center for Eye Diseases),Shanghai,China
Scopus学科分类	Ophthalmology;Sensory Systems;Cellular and Molecular Neuroscience
引用统计	被引频次：5[WOS] [WOS记录] [WOS相关记录]
文献类型	期刊论文
条目标识符	https://kms.wmu.edu.cn/handle/3ETUA0LF/20804
专题	眼视光学院（生物医学工程学院）、附属眼视光医院_儿童眼底病专科
通讯作者	Xu, Xun
作者单位	1.Department of Ophthalmology (Aka National Clinical Research Center for Eye Diseases),Shanghai General Hospital,Shanghai,China; 2.School of Medicine,Shanghai Jiao Tong University,Shanghai,China; 3.Admin Office,Eye Specialist Hospital,Liaoning,China; 4.Department of Ophthalmology,Army Medical Center of PLA,Chongqing,China; 5.Department of Ophthalmology,Wuhan General Hospital of Guangzhou Military Region,Wuhan,China; 6.Department of Ophthalmology,Xijing Hospital,Shaanxi,China; 7.Department of Ophthalmology,Fourth Military Medical University,Shaanxi,China; 8.Department of Ocular Fundus Disease,Wenzhou Medical University Eye Hospital,Wenzhou,China; 9.Department of Ophthalmology,Wuxi No 2 People's Hospital,Jiangsu,China; 10.Department of Ophthalmology,Third Military Medical University Southwest Hospital,Chongqing,China; 11.Henan Eye Institute,Henan Eye Hospital,People's Hospital of Zhengzhou University,Henan Provincial People's Hospital,Zhengzhou,China; 12.Department of Ophthalmology,Peking University Third Hospital,Beijing,China; 13.Department of Ophthalmology,Beijing Tongren Hospital,Beijing,China; 14.Department of Ophthalmology,Capital Medical University,Beijing,China; 15.Department of Ocular Fundus Disease,Tianjin Medical University Eye Hospital,Tianjin,China; 16.Department of Ophthalmology,Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital,Shanghai,China; 17.Department of Ophthalmology,Sichuan University West China Hospital,Chengdu,China; 18.Department of Ophthalmology,First Affiliated Hospital of Chongqing Medical University,Chongqing,China; 19.Department of Ophthalmology,Peking Union Medical College Hospital,Dongcheng-qu,China; 20.Zhongshan Ophthalmic Center,Sun Yat-Sen University,Guangdong,China; 21.Department of Ophthalmology,Peking University People's Hospital,Beijing,China; 22.Medical Research Center,Chengdu Kanghong Biotechnology Inc,Sichuan,China; 23.Medicial Department,Chengdu Kanghong Biotechnology Inc,Sichuan,China; 24.Bascom Palmer Eye Institute,University of Miami Health System,Miami,United States; 25.Retina,Ophthalmic Consultants of Boston,Boston,United States; 26.Cole Eye Institute,Cleveland Clinic,Cleveland,United States
推荐引用方式 GB/T 7714	Liu, Kun,Wang, Hanying,He, Wei,et al. Intravitreal conbercept for diabetic macular oedema: 2-year results from a randomised controlled trial and open-label extension study[J]. BRITISH JOURNAL OF OPHTHALMOLOGY,2022,106(10):1436-1443.
APA	Liu, Kun., Wang, Hanying., He, Wei., Ye, Jian., Song, Yanping., ... & Xu, Xun. (2022). Intravitreal conbercept for diabetic macular oedema: 2-year results from a randomised controlled trial and open-label extension study. BRITISH JOURNAL OF OPHTHALMOLOGY, 106(10), 1436-1443.
MLA	Liu, Kun,et al."Intravitreal conbercept for diabetic macular oedema: 2-year results from a randomised controlled trial and open-label extension study".BRITISH JOURNAL OF OPHTHALMOLOGY 106.10(2022):1436-1443.