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
机构：[1]Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, 1, Shuai Fu Yuan, Dongcheng District, Beijing 100730, China[2]Eye Center of People’s Hospital, Peking University, Beijing, China[3]Zhongshan Ophthalmic Center, Sun-Yat-sen University, Guangzhou, China[4]Eyes and ENT Hospital of Fudan University, Shanghai, China[5]Shanghai First People’s Hospital, Jiao Tong University, Shanghai, China[6]Beijing Tongren Hospital, Beijing, China首都医科大学附属北京同仁医院首都医科大学附属同仁医院[7]West China Hospital, Sichuan University, Sichuan, China四川大学华西医院[8]Novartis Pharma AG, Basel, Switzerland
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.
第一作者机构：[1]Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, 1, Shuai Fu Yuan, Dongcheng District, Beijing 100730, China
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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.doi:10.1007/s40259-014-0106-1.
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)
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
