Long-Term Non-Interventional Study (NIS) To Investigate The Safety And Effectiveness 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
- 108
- 试验地点
- 1
- 主要终点
- Change From Baseline in Visual Acuity (VA) at Final Visit
研究概览
简要总结
To define what procedures were used for the diagnosis and monitoring of the treatment age-related macular degeneration (AMD). What is the effect of the Macugen, compliance with Macugen treatment, safety profile of Macugen, final physician assessment of treatment with Macugen.
详细描述
no sampling
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18 years old
- •patients with neovascular age-related macular degeneration
- •enrollment to study is fully on physician decision in compliance with current SPC
排除标准
- •Patient who did not meet indication according to SPC Macugen.
结局指标
主要结局
Change From Baseline in Visual Acuity (VA) at Final Visit
时间窗: Baseline, Final Visit (Week 104 or early termination [ET])
Visual acuity (VA) measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as Logarithm of Minimum Angle of Resolution (logMAR), logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.
次要结局
- Physician's Assessment of Efficacy(Week 104 or End of study (EOS))
- Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination(Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102)
- Change From Baseline in Visual Acuity (VA) at Each Visit(Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102)