NCT02289924已完成不适用
PERSEUS-IT. A Prospective Non-intERventional Study to asSEss the Effectiveness of Aflibercept (Eylea®) in roUtine Clinical Practice in patientS With Wet Age-related Macular Degeneration in Italy
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
- 912
- 主要终点
- Mean change of visual acuity from baseline to 12 months.
研究概览
简要总结
The main objectives of this non-interventional cohort field study are to evaluate effectiveness of Eylea and to describe follow-up as well as treatment patterns in patients with wAMD (wet age-related macular degeneration) in routine clinical practice in Italy for a study population of "naïve" patients
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
- •"Naïve" patients with wet AMD(age-related macular degeneration) treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC).
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.
- •Any prior or concomitant therapy with another drug for wAMD.
研究组 & 干预措施
Cohort 1
According to the recommendations of the Summary of Product Characteristics (SmPC) in Italy
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 from baseline to 12 months.
时间窗: Baseline to 12 months
Mean change of visual acuity from baseline to 24 months.
时间窗: Baseline to 24 months
次要结局
- Mean time between the injections and visits(At 12 and 24 months)
- Proportion of patients with no fluid(At 4,12 and 24 months)
- Number of post-injection monitoring visits (visits only for safety checks after injection)(At 12 and 24 months)
- Mean time between the first symptoms and diagnosis(Up to 24 months)
- Mean time from indication of the Eylea treatment by the treating physician to treatment(Up to 24 months)
- Number of clinical visits (visits for injections)(At 12 and 24 months)
- Number of monitoring visits (visits only for diagnostic purposes, but without injections)(At 12 and 24 months)
- Number of combined visits (visits for monitoring and injection)(At 12 and 24 months)
- Number of visits outside the study center after 12 and 24 months(At 12 and 24 months)
- Number of optical coherence tomography (OCT) assessments per patient(At 12 and 24 months)
- Number of visual acuity tests(At 12 and 24 months)
- Number of fundoscopy examinations(At 12 and 24 months)
- Mean change in retinal thickness from baseline(Baseline and at 4,12 and 24 months)
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