Long-Term Non-Interventional Study To Investigate The Efficacy And Safety Of MACUGEN In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Change From Baseline Visual Acuity (VA) at the Final Visit
研究概览
简要总结
Efficacy and safety of MACUGEN in patients suffering from neovascular age-related macular degeneration in routine clinical practice at least as good as demonstrated in randomized multicenter clinical trials.
详细描述
Eligible patients in routine clinical practice
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults with neovascular age-related macula degeneration
排除标准
- •according to SmPC
研究组 & 干预措施
Patients with neovascular Age-Related Macula Degeneration
干预措施: pegaptanib sodium (Drug)
结局指标
主要结局
Change From Baseline Visual Acuity (VA) at the Final Visit
时间窗: Baseline, Week 102 or Early Termination (ET)
VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.
次要结局
- Change From Baseline VA at Each Visit(Baseline, every 6 weeks up to Week 102)
- Change From Baseline VA at the Final Visit for Participants With Vascular Retinal Pigment Epithelial Detachment (RPED)(Baseline, Week 102 or ET)
- Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit(Baseline, Month 6, 12, 18, and 24)
- Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit(Baseline, Week 102 or ET)
- Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit(Baseline, Week 102 or ET)