| Title | Efficacy and safety of ranibizumab 0.5 mg in Chinese patients with visual impairment due to diabetic macular edema: results from the 12-month REFINE study |
| Authors | Li, Xiaoxin Dai, Hong Li, Xiaorong Han, Mei Li, Jun Suhner, Andrea Lin, Renxin Wolf, Sebastian Li, Xiaoxin Qi, Huijun Tao, Ye Li, Yan Bai, Yujing Yin, Hong Liu, Guodong Han, Li Qian, Tong Huang, Lvzhen Miao, Heng Zhao, Mingwei Hou, Jing Cheng, Yong Liang, Jianhong Shi, Xuan Qu, Jinfeng Yu, Wenzhen Tao, Yong Chen, Yi Zhang, Feng Shi, Xuehui Gao, Liqin Ding, Ning Yang, Lihong Zhao, Shiqiang Yang, Qiong Shen, Rong Xiong, Ying Dong, Fangtian Zhang, Xiao Gong, Di Qu, Yi Dai, Fangfang He, Feng Han, Xiaoxu Dai, Rongping Du, Hong Yu, Weihong Li, Donghui Yang, Zhikun Ma, Zhizhong Zhang, Min Dou, Hongliang Chen, Xiuhong Chu, Ying Ren, Jing Qian, Fang Yang, Fan Zhao, Lin Ding, Aihua Guo, Tong Lu, Xinrong Liu, Yuling Wang, Xin Yang, Liu Li, Jun Zhu, Ruilin Hao, Jianchen Qiao, Lijun Guo, Chunying Zhang, Jing Nie, Hongping Gu, Xiaopeng Du, Lixiao Zhang, Yadi Zhang, Wenbo Zhang, Shijie Hao, Jianchen Zhao, Liang Shi, Jingmei Wu, Hailong Dai, Hong Huang, Jianfeng Zhao, Jing Hu, Lei Yu, Xiaobing Lu, Yingyi Peng, Nuan Gu, Xiaoya Long, Li Shi, Zian Wang, Yanling Zhao, Lu Zhang, Xiaolei Hou, Yanli Huang, Yinxiang Li, Mingming Zhang, Fan Hong, Hui Wang, Kang Tang, Simeng Liu, Dachuan Junjie, Bian lei, Zhang Dai, Weijia Huiqing, Yang Ning, Hao Wang, Xizhe Zhao, Liyan Li, Xiaorong Wang, Shaorui Wang, Linni Han, Jindong Chen, Lu Ma, Jinghua Ma, He Li, Zhiqing Wang, Tingting Yu, Rongguo Dong, Xiaojun Li, Ying Guo, Junlin Hu, Yahan Sheng, Xueyong Li, Shuang Han, Mei Cong, Chunxia Li, Li Han, Ying Xu, Yanshan Ma, Nannan Xie, Shiyong Lu, Lin Hu, Andina Lian, Ping Ma, Wei Su, Guangxing Yuan, Miner Lai, Wangying Li, Xiaofang Chen, Guangxian Yu, Xiling Mai, Guiying Zhong, Junying Chen, Xing Liu, Bingqian Liu, Yuhong Zhao, Xiujuan Mo, Qinmei Cheng, Jiangmei Yang, Hui Yang, Qiufen Zhong, Xiaojing Jin, Chenjin He, Caiqing Xie, Qiuhua Huang, Ping Mai, Xiaoxi Zhong, Jingxiang Zhang, Xiaoming Liu, Xiaoyong Zhang, Ting Zhang, Liqiong Wang, Guifang He, Xiaojuan Meng, Jing Zhang, Rijia Tian, Yuan Chen, Weiqi Chen, Shirong Huang, Bingrong Zhang, Guihua Zhang, Anlin Liu, Xinyu Zheng, Kangkeng Zhou, Lingling Chen, Haoyu Peng, Kun Zhou, Zhaotao Lin, Dusheng Huang, Huichun Lin, Xiaoang Zhang, Junjun Zhang, Meixia Zhu, Helian Huang, Xi Xin, Mei Zeng, Zhibing Meng, Dan Wu, Ye Wu, Qianying Ma, Lin Lai, Zhifeng Gao, Sheng Wang, Xiaoyue Ren, Juqin Qiu, Guoxian Ye, Jian Liao, Hongxia Tang, Ying Tao, Lusha Liu, Shaozhang Yue, Li Feng, Sijia Xu, Jie Dong, Yan Tan, Nian Chen, Yanli Chen, Shaoqiong Zhao, Peiquan Wang, Zhaoyang Dong, Yang Man, Xiaofei Ji, Xunda Tian, Tian Feng, Huazhang Li, Xin Huang, Qiujing Wang, Shiyuan Cai, Kebo Zhang, Qi Li, Yian Jin, Haiying Sun, Xiaodong Zheng, Kairong Feng, Jingyang Ye, Liang Shih, Alice Liu, Xiaoxiao Cai, Zhengyuan Wu, Ying Fan, Ying He, Ping Xie, Liping Sun, Jian Duan, Zhongju Zhao, Tingting Wang, Weijun Cheng, Lu Yao, Pang Wu, Zhifeng Xu, Huiyan Zhang, Jie Zhu, Dongyuan Meng, Xiaomei Fu, Yuting Chen, Tiantian Lu, Shui Zou, Wenjun Shen, Ye Tong, Jianping Yu, Chengying Lu, Hong Wu, Qin Fan, Wenting Huang, Baishuang Wang, Xiaoen Hong, Nan Wu, Miaoqin Li, Xiaoxia Zheng, Qingqing Chen, Yurong Xu, Hong Liu, Hui Liu, Zhe Shen, Ting Guo, Hong Zhang, Luyi Chi, Xinchang Zhao, Hailan Yu, Jie Zhang, Lan Song, Yanping Ding, Qin Qiu, Jinlan Liu, Yan Dong, Yangting Chang, Feng Chen, Zhongshan Chen, Yunhui Yan, Ming Huang, Zhen Huang, Zhijian Ma, Lina Du, Qian Zhang, Mingchang Li, Pengcheng Yan, Wenhui Zheng, Hai Xu, Kangkang Fang, Jing Wei, Jingjing Yang, Junjie Sheng, Shuangyan Ao, Qiong Liu, Xiaoling Ge, Lina Zhou, Tingye Zhu, Qianqian Lin, Bing Luo, Yingdong Huang, Ying Zeng, Leilei Zheng, Weiwei Yan, Miaojun Sun, Zuhua Wang, Yusheng Zhang, Peng Wang, Haiyan Zhu, Jinting Yu, Xiaoni Li, Manhong Wang, Qihua Li, Juan Bai, Wenle Hou, Huiyuan Zhang, Zifeng He, Jin Sun, Dongjie Song, Xiaojin Tang, Luosheng Zhao, Fei Zhang, Kun Ouyang, Pingbo Zeng, Jun Liu, Jia Wei, Wei Tian, Jiao Xu, Haifeng Li, Jun Xu, Jing Wang, Min Shi, Depeng Wu, Peipei Sun, Dawei Shi, Liping Jiang, Bo Cheng, Fang Jia, Danhua Zhang, Zhongyu Zhou, Xuemei Song, Wulian Shen, Ling Fan, Pan Yi, Jinglin Yang, Haijun Zuo, Yanping Zeng, Jiao Liu, Yan Du, Hongyan Yu, Li Liu, Xian Wan, Shenghui Zhu, Si Li, Qiulin Dong, Wenjia |
| Affiliation | Peking Univ Peoples Hosp, Dept Ophthalmol, 11 Xi Zhi Men South Ave, Beijing 100044, Peoples R China Beijing Hosp, Dept Ophthalmol, Natl Ctr Gerontol, Beijing, Peoples R China Tianjin Med Univ Eye Hosp, Tianjin, Peoples R China Tianjin Eye Hosp, Tianjin, Peoples R China Novartis Pharma AG, Basel, Switzerland China Novartis Inst BioMed Res Co Ltd, Shanghai, Peoples R China Univ Hosp Bern, Univ Bern, Dept Ophthalmol, Inselspital, Bern, Switzerland Peking Univ Peoples Hosp, Beijing 100044, Beijing, Peoples R China Beijing Tongren Hosptial, Beijing 100176, Beijing, Peoples R China Hosp Beijing, Peking Union Med Coll, Beijing 100730, Peoples R China Peking Univ Third Hosp, Beijing 100191, Beijing, Peoples R China Peking Univ First Hosp, Beijing 100034, Beijing, Peoples R China Beijing Hosp, Beijing 100730, Beijing, Peoples R China Friendship Hosp, Beijing 100050, Beijing, Peoples R China Beijing Univ, Xuan Wu Hosp Capital Med, Beijing 100053, Peoples R China Tianjin Med Univ Eye Hosp, Tianjin 300020, Tianjin, Peoples R China Tianjin Eye Hosp, Tianjin 300070, Tianjin, Peoples R China Sun Yat Sen Univ, Zhongshan Ophthalm Ctr, Guangzhou 510060, Guangdong, Peoples R China First Affiliated Hosp Jinan Univ Guangzhou, Guangzhou 510632, Guangdong, Peoples R China Shantou Univ, Shantou Int Eye Ctr, Shantou 515041, Guangdong, Peoples R China Sichuan Univ, West China Hosp, Chengdu 610041, Sichuan, Peoples R China Third Mil Med Univ Daping Hos, 3 Hosp, Chongqing 400042, Chongqing, Peoples R China Shanghai XinHua Hosp Shanghai, Shanghai 200092, Peoples R China Shanghai Gen Hosp, Shanghai 200080, Shanghai, Peoples R China Wuxi 2 Peoples Hosp, Wuxi, Jiangsu, Peoples R China Zhejiang Univ, First Affiliated Hosp, Hangzhou 310003, Zhejiang, Peoples R China Zhejiang Prov Peoples Hosp, Hangzhou, Zhejiang, Peoples R China Wuhan Gen Hosp Guangzhou Mil, Wuhan 430070, Hubei, Peoples R China Wuhan Union Hosp, Wuhan 430022, Hubei, Peoples R China Wenzhou Med Univ, Affiliated Eye Hosp, Wenzhou 325027, Zhejiang, Peoples R China First Affiliated Hosp Fourth Mil Med Xian, Xian 710032, Shaanxi, Peoples R China Second Xiangya Hosp Cent South Univ, Changsha 410011, Hunan, Peoples R China Qingdao Eye Hosp, Qingdao, Shandong, Peoples R China 2 Affiliated Hosp Harbin Med Univ, Harbin 150086, Heilongjiang, Peoples R China Affiliated Eye Hosp Nanchang Univ, Nanchang 330019, Jiangxi, Peoples R China |
| Keywords | Anti-vascular endothelial growth factor Diabetic macular edema Pro re nata Ranibizumab |
| Issue Date | 2019 |
| Publisher | GRAEFES ARCHIVE FOR CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY |
| Abstract | PurposeTo demonstrate the efficacy and safety of ranibizumab 0.5mg pro re nata (PRN) versus laser photocoagulation for the treatment of Chinese patients with visual impairment due to diabetic macular edema (DME).MethodsREFINE was a phase III, 12-month, double-masked, multicenter, laser-controlled study in patients (aged 18years) with DME. Patients were randomized 4:1 to receive either ranibizumab 0.5mg or laser dosing regimen. Efficacy was evaluated as mean average change in best-corrected visual acuity (BCVA) from Months 1 to 12 versus baseline (primary endpoint), anatomical outcomes, treatment exposure, and safety were also assessed.ResultsRanibizumab was statistically superior (p<0.001) to laser treatment, with a mean average BCVA gain of 6.8 letters (ranibizumab) over 12months versus 1.1 letters (laser). At Month 12, mean BCVA gain was 7.8 letters (ranibizumab) and 2.5 letters (laser) from baseline. Patients in the ranibizumab arm received a mean number of 7.9 intravitreal injections, whereas those in the laser arm received a mean of 2.1 treatments. There were no new safety signals.ConclusionRanibizumab 0.5mg PRN demonstrated a statistically significant and clinically meaningful treatment effect versus laser and was well tolerated in Chinese patients with visual impairment due to DME over 12months. |
| URI | http://hdl.handle.net/20.500.11897/550339 |
| ISSN | 0721-832X |
| DOI | 10.1007/s00417-018-04213-x |
| Indexed | SCI(E) |
| Appears in Collections: | 人民医院 第三医院 第一医院 |
