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

被引：20

作者：

Li, Xiaoxin ^{[1
,8
]}

Dai, Hong ^{[2
,13
]}

Li, Xiaorong ^{[3
,16
]}

Han, Mei ^{[4
,17
]}

Li, Jun ^{[5
,12
,32
]}

Suhner, Andrea ^{[6
]}

Lin, Renxin

Wolf, Sebastian ^{[7
]}

Li, Xiaoxin ^{[1
,8
]}

Qi, Huijun ^{[8
]}

Tao, Ye ^{[8
]}

Li, Yan ^{[8
]}

Bai, Yujing ^{[8
]}

Yin, Hong ^{[8
]}

Liu, Guodong ^{[8
]}

Han, Li ^{[8
]}

Qian, Tong ^{[8
]}

Huang, Lvzhen ^{[8
]}

Miao, Heng ^{[8
]}

Zhao, Mingwei ^{[8
]}

Hou, Jing ^{[8
]}

Cheng, Yong ^{[8
]}

Liang, Jianhong ^{[8
]}

Shi, Xuan ^{[8
]}

Qu, Jinfeng ^{[8
]}

Yu, Wenzhen ^{[8
]}

Tao, Yong ^{[8
]}

Chen, Yi ^{[8
]}

Zhang, Feng ^{[9
]}

Shi, Xuehui ^{[9
]}

Gao, Liqin ^{[9
]}

Ding, Ning ^{[9
]}

Yang, Lihong ^{[9
]}

Zhao, Shiqiang ^{[9
]}

Yang, Qiong ^{[9
]}

Shen, Rong ^{[9
]}

Xiong, Ying ^{[9
]}

Dong, Fangtian ^{[10
]}

Zhang, Xiao ^{[10
]}

Gong, Di ^{[10
]}

Qu, Yi ^{[10
]}

Dai, Fangfang ^{[10
]}

He, Feng ^{[10
]}

Han, Xiaoxu ^{[10
]}

Dai, Rongping ^{[10
]}

Du, Hong ^{[10
]}

Yu, Weihong ^{[10
]}

Li, Donghui ^{[10
]}

Yang, Zhikun ^{[10
]}

Ma, Zhizhong ^{[11
]}

机构：

[1] Peking Univ Peoples Hosp, Dept Ophthalmol, 11 Xi Zhi Men South Ave, Beijing 100044, Peoples R China

[2] Beijing Hosp, Dept Ophthalmol, Natl Ctr Gerontol, Beijing, Peoples R China

[3] Tianjin Med Univ Eye Hosp, Tianjin, Peoples R China

[4] Tianjin Eye Hosp, Tianjin, Peoples R China

[5] Novartis Pharma AG, Basel, Switzerland

[6] China Novartis Inst BioMed Res Co Ltd, Shanghai, Peoples R China

[7] Univ Hosp Bern, Univ Bern, Dept Ophthalmol, Inselspital, Bern, Switzerland

[8] Peking Univ Peoples Hosp, Beijing 100044, Beijing, Peoples R China

[9] Beijing Tongren Hosptial, Beijing 100176, Beijing, Peoples R China

[10] Hosp Beijing, Peking Union Med Coll, Beijing 100730, Peoples R China

[11] Peking Univ Third Hosp, Beijing 100191, Beijing, Peoples R China

[12] Peking Univ First Hosp, Beijing 100034, Beijing, Peoples R China

[13] Beijing Hosp, Beijing 100730, Beijing, Peoples R China

[14] Friendship Hosp, Beijing 100050, Beijing, Peoples R China

[15] Beijing Univ, Xuan Wu Hosp Capital Med, Beijing 100053, Peoples R China

[16] Tianjin Med Univ Eye Hosp, Tianjin 300020, Tianjin, Peoples R China

[17] Tianjin Eye Hosp, Tianjin 300070, Tianjin, Peoples R China

[18] Sun Yat Sen Univ, Zhongshan Ophthalm Ctr, Guangzhou 510060, Guangdong, Peoples R China

[19] First Affiliated Hosp Jinan Univ Guangzhou, Guangzhou 510632, Guangdong, Peoples R China

[20] Shantou Univ, Shantou Int Eye Ctr, Shantou 515041, Guangdong, Peoples R China

[21] Sichuan Univ, West China Hosp, Chengdu 610041, Sichuan, Peoples R China

[22] Shanghai XinHua Hosp Shanghai, Shanghai 200092, Peoples R China

[23] Shanghai Gen Hosp, Shanghai 200080, Shanghai, Peoples R China

[24] Wuxi 2 Peoples Hosp, Wuxi, Jiangsu, Peoples R China

[25] Zhejiang Univ, Affiliated Hosp 1, Hangzhou 310003, Zhejiang, Peoples R China

[26] Zhejiang Prov Peoples Hosp, Hangzhou, Zhejiang, Peoples R China

[27] Wuhan Gen Hosp Guangzhou Mil, Wuhan 430070, Hubei, Peoples R China

[28] Wuhan Union Hosp, Wuhan 430022, Hubei, Peoples R China

[29] Wenzhou Med Univ, Affiliated Eye Hosp, Wenzhou 325027, Zhejiang, Peoples R China

[30] First Affiliated Hosp Fourth Mil Med Xian, Xian 710032, Shaanxi, Peoples R China

[31] Second Xiangya Hosp Cent South Univ, Changsha 410011, Hunan, Peoples R China

[32] Qingdao Eye Hosp, Qingdao, Shandong, Peoples R China

[33] 2 Affiliated Hosp Harbin Med Univ, Harbin 150086, Heilongjiang, Peoples R China

[34] Affiliated Eye Hosp Nanchang Univ, Nanchang 330019, Jiangxi, Peoples R China

来源：

GRAEFES ARCHIVE FOR CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY | 2019年 / 257卷 / 03期

关键词：

Anti-vascular endothelial growth factor; Diabetic macular edema; Pro re nata; Ranibizumab; RISK-FACTORS; AQUEOUS-HUMOR; RETINOPATHY; PREVALENCE; EPIDEMIOLOGY;

D O I：

10.1007/s00417-018-04213-x

中图分类号：

R77 [眼科学];

学科分类号：

100212 ;

摘要：

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.

引用

页码：529 / 541

页数：13

共 50 条

[1] 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
Xiaoxin Li
Hong Dai
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[J]. Graefe's Archive for Clinical and Experimental Ophthalmology, 2019, 257 : 529 - 541
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[9] LONG-TERM SAFETY AND EFFICACY OUTCOME OF RANIBIZUMAB 0.5 MG IN PATIENTS WITH VISUAL IMPAIRMENT DUE TO DIABETIC MACULAR EDEMA: THE RESTORE EXTENSION STUDY
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