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学科主题: 临床医学
题名:
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
作者: Zhao, Jialiang1; Li, Xiaoxin2; Tang, Shibo3; Xu, Gezhi4; Xu, Xun5; Zhang, Feng6; Zhang, Meixia7; Shamsazar, Jila8; Pilz, Stefan8; Nieweg, Annette8
刊名: BIODRUGS
发表日期: 2014-12-01
DOI: 10.1007/s40259-014-0106-1
卷: 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
项目资助者: Novartis Pharma AG, Switzerland
WOS记录号: WOS:000345993600005
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/52601
Appears in Collections:北京大学第二临床医学院_眼科_期刊论文

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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

Recommended Citation:
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.
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