EUCTR2014-004886-26-IT进行中（未招募）1 期
A Two-Year, Randomized, Double-Masked, Multicenter, Two-Arm StudyComparing the Efficacy and Safety of RTH258 6mg Versus Aflibercept inSubjects with Neovascular Age-Related Macular Degeneration - RTH258 6 mg in patients with retina damage such as growth of abnormal
ALCON RESEARCH. LTD.0 个研究点目标入组 660 人开始时间: 2018年12月10日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 660
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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: 1
- •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
排除标准
- •Any active intraocular or periocular infection or active intraocular
- •inflammation in either eye
- •Central subfield of the study eye affected by fibrosis or geographic
- •Subject has received any approved or investigational treatment for
- •neovascular AMD (other than vitamin supplements) in the study eye at
- •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.
研究者
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