A Two-Year, Randomized, Double-Masked, Multicenter, Two-Arm Study Comparing the Efficacy and Safety of RTH258 6mg Versus Aflibercept in Subjects with Neovascular Age-Related Macular Degeneration - Efficacy and Safety of RTH258 versus Aflibercept

Alcon Research Ltd0 个研究点目标入组 660 人开始时间: 2015年6月15日最近更新: 2018年3月19日

研究概览

暂无简介。

•Subjects must give written informed consent
•Subjects must be 50 years of age or older
•Active CNV lesions secondary to AMD that affect the central subfield in the study eye
•Total area of CNV must comprise as stated in the protocol
•Other protocol-defined inclusion criteria may apply.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 46
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 614

•Any active intraocular or periocular infection or active intraocular inflammation in either eye
•Central subfield of the study eye affected by fibrosis or geographic atrophy
•Subject has received any approved or investigational treatment for neovascular AMD (other
•than vitamin supplements) in the study eye at any time.
•History or evidence of the following in the study eye:
•Intraocular or refractive surgery
•Uncontrolled glaucoma as defined in the protocol
•Treatment with aflibercept (EYLEA®), bevacizumab (AVASTIN®) or pegaptanib
•(MACUGEN®) within the 4 week period prior to Baseline, or with Ranibizumab, 0.5 mg (LUCENTIS®) within the 2 week period prior to Baseline
•Stroke or myocardial infarction or uncontrolled blood pressure
•Other protocol-defined exclusion criteria may apply.

发起方