NCT01914380已完成不适用
PERSEUS - A Prospective Non-interventional Study to Assess the Effectiveness of Aflibercept (Eylea®) in Routine Clinical Practice in Patients With Wet Age-related Macular Degeneration
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 988
- 主要终点
- Mean change of visual acuity for the total patient population
研究概览
简要总结
The study aims to investigate the effectiveness of Eylea in patients with wet age-related macular degeneration in routine clinical practice in Germany. The study is purely observational, only data from routine treatment are to be collected. The treatment and treatment conditions are solely at discretion of the treating physician.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with wet wAMD treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC).
- •Written informed consent.
排除标准
- •Exclusion criteria as listed in the local SPC.
- •Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
- •Any concomitant therapy with another agent to treat wet AMD in the study eye.
研究组 & 干预措施
Group 1
干预措施: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) (Drug)
结局指标
主要结局
Mean change of visual acuity for the total patient population
时间窗: Baseline, 12 and 24 months
Mean change of visual acuity for the subgroup of pretreated patients
时间窗: Baseline, 12 and 24 months
Mean change of visual acuity for the subgroup of non-pretreated patients
时间窗: Baseline, 12 and 24 months
次要结局
- Monitoring of disease activity(after 12 and 24 months)
- Monitoring of treatment patterns(after 12 and 24 months)
- Mean time from indication of Eylea-treatment by the treating physician to start of treatment(after 12 and 24 months)
研究者
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