题名 | Intravitreal conbercept for diabetic macular oedema: 2-year results from a randomised controlled trial and open-label extension study |
作者 | Liu, Kun1,2; Wang, Hanying1,2; He, Wei3; Ye, Jian4; Song, Yanping5; Wang, Yusheng6,7; Liu, Xiaoling8; Wu, Zhifeng9; Chen, Shaojun10; Fan, Ke11; Liu, Yuling12; Zhang, Feng13,14; Li, Zhiqing15; Liu, Lin16; Zhang, Junjun17; Zhang, Xuedong18; Ye, Junjie19; Liang, Xiaoling20; Li, Xiaoxin21; Ke, Xiao22; Wu, Quan22; Li, Jie23; Tao, Shanshan23; Wang, Xinguo22; Rosenfeld, Philip24; Heier, Jeffrey S25; Kaiser, Peter26; Xu, Xun1,2
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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 |
TOP期刊 | TOP期刊 |
引用统计 | |
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. |
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