Special Drug Use Investigation of EYLEA for AMD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 3,872
- 主要终点
- Number of participants with serious adverse events (SAEs) and ocular adverse events(AEs) (especially AEs due to ITV injection procedure) from the first ITV injection of EYLEA
研究概览
简要总结
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received EYLEA for Age-Related Macular Degeneration (AMD).
The objective of this study is to assess safety and effectiveness of EYLEA using in real clinical practice.
A total of 4,000 patients are to be enrolled and assessed in 3 years standard observational period. An annual follow-up survey will be conducted for 5 years at the longest after standard observational period.
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 received EYLEA for AMD
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
Number of participants with serious adverse events (SAEs) and ocular adverse events(AEs) (especially AEs due to ITV injection procedure) from the first ITV injection of EYLEA
时间窗: Up to 3 years
Number of participants with adverse drug reactions(ADRs) and infections from the first intravitreal(ITV) injection of EYLEA
时间窗: Up to 3 years
次要结局
- Mean changes in visual acuity(Baseline and 6, 24 or 36 months)
- Number of participants with ADRs, SAEs and ocular AEs ( especially AEs due to ITV injection procedure) in subpopulations of patients background characteristics and status of EYLEA treatments from the first ITV injection of EYLEA(Up to 3 years)
- Proportion of patients who maintained visual acuity(corresponding to <15 letters of Early Treatment Diabetic Retinopathy Study(ETDRS) from baseline) and improved visual acuity(corresponding to >0 letter of ETDRS from baseline)(Up to 3 years)
- Mean changes in visual acuity in subpopulations of patients background characteristics and status of EYLEA treatments(Baseline and 6, 24 or 36 months)
- Number and intervals of ITV injection of EYLEA(Up to 3 years)