PMS Registry
Company Name
Novartis Taiwan
Protocol Number
CRFB002ATW04
Title of Study
RACER (Ranibizumab AMD Clinical Efficacy in Real world practice): A multicenter, open-label, prospective, non-interventional study to evaluate the effectiveness and safety of Lucentis (ranibizumab) in naive wet Age-Related Macular Degeneration (wAMD) patients with vision impairment due to choroidal neovavscularization (CNV) over a 12-month observational period under real life conditions RACER (臨床評估年齡相關性黃斑部退化病變病患使用 ranibizumab 治療之有效性):一項為期 12 個月,多中心、開放性、前瞻性、非介入性研究,觀察臨床使用樂舒晴(Lucentis®/ranibizumab)治療血管新生型(濕性)年齡相關性黃斑部退化病變 (wAMD)引起脈絡膜血管新生(CNV)而導致視覺障礙,且未曾接受過治療之病患,其有效性與安全性評估。
Primary Objective
To observe the effectiveness (Best-corrected Visual Acuity, BCVA) at month 3 post initiation of ranibizumab treatment 觀察使用樂舒晴(Lucentis®/ranibizumab) 治療後第3 個月,以最佳矯正視力(BCVA)為有效性之評估。
Number of Sites
7
Period of Study
From:26-Apr-2014 to:31-Mar-2016
Number of Patients
160人
IRB Approval Date
11-Feb-2014 (the earliest approved site)
Publication Plan / Date
Dec 2016