EUCTR2013-002124-17-ES进行中(未招募)1 期
Phase IV study to evaluate genetic variants of VEGF pathway as biomarkers of VEGF Trap-Eye treatment efficacy in subjects with neovascular age-related macular degeneration (wAMD). - BIOIMAGE
Fundació de Recerca de L?Institut de Microcirurgia Ocular0 个研究点开始时间: 2013年8月8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
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
- •? Men and women ? 50 years of age.
- •? Active primary subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.
- •? ETDRS best-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye at 4 meters.
- •? Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 124
排除标准
- •? Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD,except dietary supplements or vitamins.
- •? Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
- •? Prior treatment with anti-VEGF therapy in the study eye is not allowed
- •? No inflammation / infection in or around the eye
- •? Known hypersensitivity and allergies.
- •? Ocular surgery in the past other than cataract surgery.
- •? No other ocular disease that could lead to decrease of VA.
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