Special Drug Use Investigation of EYLEA for Diabetic Macular Edema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 646
- 主要终点
- Number of participants of Adverse Events
研究概览
简要总结
The objectives of this study are to investigate the safety and effectiveness of EYLEA
详细描述
This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of myopic choroidal neovascularization. The investigator will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert prior to enrolling the patient in this study.
The observation period for each patient starts when therapy with EYLEA is initiated. The enrollment period is 2 years. Patients will be followed for a time period of 2 years or until it is no longer possible (e.g. lost to follow-up) within the 2 years. In total, 600 patients will be recruited.
For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice).
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 start EYLEA treatment for Diabetic Macular Edema (DME)
排除标准
- •Patients who have already received EYLEA treatment
研究组 & 干预措施
Aflibercept (Eylea,BAY86-5321)
Decision of EYLEA treatment is made by attending investigator according to the Japanese Package Insert
干预措施: Aflibercept (Eylea, BAY86-5321) (Drug)
结局指标
主要结局
Number of participants of Adverse Events
时间窗: Up to 12 months
Number of participants of Serious Adverse Events
时间窗: Up to 12 months
次要结局
- Mean change in visual acuity from baseline to 12 months(Baseline to 12 months)
- Mean change in retina thickness from baseline to 12 months(Baseline to 12 months)