IR@PKUHSC  > 北京大学第二临床医学院  > 眼科
学科主题临床医学
EXTEND II: An Open-Label Phase III Multicentre Study to Evaluate Efficacy and Safety of Ranibizumab in Chinese Patients with Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Zhao, Jialiang1; Li, Xiaoxin2; Tang, Shibo3; Xu, Gezhi4; Xu, Xun5; Zhang, Feng6; Zhang, Meixia7; Shamsazar, Jila8; Pilz, Stefan8; Nieweg, Annette8
刊名BIODRUGS
2014-12-01
DOI10.1007/s40259-014-0106-1
28期:6页:527-536
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Oncology ; Immunology ; Pharmacology & Pharmacy
研究领域[WOS]Oncology ; Immunology ; Pharmacology & Pharmacy
关键词[WOS]VISUAL IMPAIRMENT ; CLINICAL-RESEARCH ; VERTEPORFIN ; EYE ; PREVALENCE ; THERAPY ; ANCHOR ; ACUITY
英文摘要

Purpose To evaluate the efficacy and safety of monthly ranibizumab 0.5 mg in Chinese patients with subfoveal choroidal neovascularization (CNV) secondary to neovascular age-related macular degeneration (nAMD).

Methods A 12-month open-label single-arm multicenter phase III study that included treatment-na < ve (study eye) patients with primary/recurrent subfoveal CNV secondary to AMD. Patients (N = 114) aged >= 50 years with best-corrected visual acuity (BCVA) of 73-24 letters were treated with monthly ranibizumab for 12 months. Main outcomes were mean BCVA change from baseline to month 4 (primary endpoint) and over time to month 12, effects of ranibizumab treatment on retinal structure (months 4 and 12), and safety.

Results Ranibizumab led to significant improvements in mean BCVA +/- standard error (SE) at both months 4 and 12 versus baseline (+9.5 +/- 1.10 letters, 95 % confidence interval [CI] 7.3-11.7, and +12.7 +/- 1.14 letters, 95 % CI 10.4-14.9, respectively, both P < 0.0001). Ranibizumab prevented loss of vision (>= 0 letters BCVA gain) in 91.2 % of patients. Mean central retinal thickness +/- SE reduced from baseline to month 12 (-119.9 +/- 12.97 mu m, 95 % CI -145.59 to -94.20, P < 0.0001). No new safety findings were reported in this study.

Conclusion Ranibizumab administered monthly over 12 months was effective in improving BCVA and was well-tolerated in Chinese nAMD patients.

语种英语
WOS记录号WOS:000345993600005
引用统计
被引频次:3[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/52601
专题北京大学第二临床医学院_眼科
作者单位1.Beijing Tongren Hosp, Beijing, Peoples R China
2.Novartis Pharma AG, Basel, Switzerland
3.Fudan Univ, Eyes & ENT Hosp, Shanghai 200433, Peoples R China
4.Chinese Acad Med Sci, Peking Union Med Coll Hosp, Beijing 100730, Peoples R China
5.Peking Univ, Peoples Hosp, Ctr Eye, Beijing 100871, Peoples R China
6.Sun Yat Sen Univ, Zhongshan Ophthalm Ctr, Guangzhou 510275, Guangdong, Peoples R China
7.Jiao Tong Univ, Shanghai Peoples Hosp 1, Shanghai 200030, Peoples R China
8.Sichuan Univ, West China Hosp, Chengdu, Sichuan, Peoples R China
推荐引用方式
GB/T 7714
Zhao, Jialiang,Li, Xiaoxin,Tang, Shibo,et al. EXTEND II: An Open-Label Phase III Multicentre Study to Evaluate Efficacy and Safety of Ranibizumab in Chinese Patients with Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration[J]. BIODRUGS,2014,28(6):527-536.
APA Zhao, Jialiang.,Li, Xiaoxin.,Tang, Shibo.,Xu, Gezhi.,Xu, Xun.,...&Nieweg, Annette.(2014).EXTEND II: An Open-Label Phase III Multicentre Study to Evaluate Efficacy and Safety of Ranibizumab in Chinese Patients with Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration.BIODRUGS,28(6),527-536.
MLA Zhao, Jialiang,et al."EXTEND II: An Open-Label Phase III Multicentre Study to Evaluate Efficacy and Safety of Ranibizumab in Chinese Patients with Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration".BIODRUGS 28.6(2014):527-536.
条目包含的文件
条目无相关文件。
个性服务
推荐该条目
保存到收藏夹
查看访问统计
导出为Endnote文件
谷歌学术
谷歌学术中相似的文章
[Zhao, Jialiang]的文章
[Li, Xiaoxin]的文章
[Tang, Shibo]的文章
百度学术
百度学术中相似的文章
[Zhao, Jialiang]的文章
[Li, Xiaoxin]的文章
[Tang, Shibo]的文章
必应学术
必应学术中相似的文章
[Zhao, Jialiang]的文章
[Li, Xiaoxin]的文章
[Tang, Shibo]的文章
相关权益政策
暂无数据
收藏/分享
所有评论 (0)
暂无评论
 

除非特别说明,本系统中所有内容都受版权保护,并保留所有权利。