Special Drug Use Investigation of EYLEA for Myopic Choroidal Neovascularization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 353
- 主要终点
- Number of episodes of Adverse drug reaction (ADR's)
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 1 years or until it is no longer possible (e.g. lost to follow-up within the 1 year ). In total, 300 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 mCNV(myopic choroidal neovascularization).
排除标准
- •Patients who have already received EYLEA treatment.
研究组 & 干预措施
Group 1
Decision of treatment is made by attending investigator according to the Japanese Package Insert
干预措施: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) (Drug)
结局指标
主要结局
Number of episodes of Adverse drug reaction (ADR's)
时间窗: Up to 12 months
Number of episodes of Infections
时间窗: Up to 12 months
Number of episodes of Serious Adverse Events(SAE's)
时间窗: Up to 12 months
Number of episodes of Ocular Adverse events
时间窗: Up to 12 months
次要结局
- Mean changes in visual acuity(Baseline up to 12 months)
- Mean changes in retina thickness(Baseline up to 12 months)