NCT01756261已完成不适用
Special Drug Use Investigation of EYLEA for Quality of Life
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
- 757
- 主要终点
- Changes in mean NEI-VFQ-25 overall scores of patients after the first intravitreal(ITV) injection of EYLEA
研究概览
简要总结
The objective of this survey is to evaluate effectiveness of EYLEA on Quality of Life (QOL). The QOL is evaluated by using Japanese version (v.1.4 - interviewer administered format) of National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) and compared at baseline and at the 6 and 12 months after start of EYLEA treatment.
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 who have been determined to start EYLEA treatment
- •Patients who are registered to Special drug use investigation of EYLEA for AMD(Trial Number 15858)
- •Patients who have agreed with the patient informed consent
排除标准
- •Patients who have already received EYLEA
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
Changes in mean NEI-VFQ-25 overall scores of patients after the first intravitreal(ITV) injection of EYLEA
时间窗: From baseline to 6 and 12 months
次要结局
- Changes in mean NEI-VFQ-25 subscale scores after the first ITV injection of EYLEA in subpopulations of patient background characteristics and status of EYLEA treatments, ie. Frequency, visual acuity, etc(From baseline to 6 and 12 months)
- Changes in mean NEI-VFQ-25 subscale scores of patients after the first ITV injection of EYLEA(From baseline to 6 and 12 months)
- Changes in mean NEI-VFQ-25 overall scores after the first ITV injection of EYLEA in subpopulations of patient background characteristics and status of EYLEA treatments, ie. Frequency, visual acuity, etc(From baseline to 6 and 12 months)
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