Drug Use Investigation for Eylea for Neovascular Glaucoma (NVG)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- The number of participants with adverse events (AEs)
研究概览
简要总结
This is a prospective, observational, multi-center and post-authorization safety study that includes patients with a diagnosis of Neovascular Glaucoma. The investigator will have made the decision to use Eylea for treatment.
The objective of this study is to assess safety and effectiveness of Eylea using in real clinical practice. Patients will be followed for a time period of 6 months from start of Eylea treatment or until it is no longer possible (e.g. lost to follow-up). In total, 480 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 visit 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
- •Diagnosis of NVG
- •Patients who have received IVT-AFL treatment according to Japanese labeling.
排除标准
- •Patients who are contraindicated based on approved label
- •Diagnosis of other indication
研究组 & 干预措施
Aflibercept (Eylea, BAY86-5321)
Decision of Eylea treatment is made by attending investigators according to the Japanese Package Insert
干预措施: Aflibercept (Eylea, BAY86-5321) (Drug)
结局指标
主要结局
The number of participants with adverse events (AEs)
时间窗: Up to 6 months
次要结局
- Intraocular Pressure (IOP) value after study drug administration(Up to 6 months)
- Mean changes in Visual Acuity(Up to 6 months)
- Proportion of participants with improvement of anterior neovascularization(Up to 6 months)