A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration (AMD) In Real Life (Macureli Study).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change From Baseline to Final Visit in Visual Acuity (VA) Score
研究概览
简要总结
To assess effectiveness of Macugen for treatment of neovascular age-related macular degeneration by measuring the evolution of visual acuity. Treatment duration, frequency of administration and combination with other treatments will also be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with subfoveal neovascular (wet) age-related macular degeneration
- •Patients having received at least 1 Macugen injection
- •Treatment naive patients, or patients having received conventional therapy
- •Patients having signed and dated informed consent.
排除标准
- •Patients participating in another clinical study with Macugen.
研究组 & 干预措施
1
Patients who obtained reimbursement of Macugen.
干预措施: Macugen (Drug)
结局指标
主要结局
Change From Baseline to Final Visit in Visual Acuity (VA) Score
时间窗: Baseline, Month 24 or Early Termination
Best corrected VA score, assessed on the scale over time (best corrected VA score at Final Visit minus best corrected VA score at Baseline). Lower scores represent poorer eyesight and higher scores represent better eyesight with a value of 1 representing normal eyesight. A positive change in score represents an improvement in sight.
次要结局
- Number of Participants With Change in VA: Improvement(Months 3, 6, 9 and 12)
- Number of Participants With Change in VA: Worsening(Months 3, 6, 9 and 12)
- Number of Participants With Change in VA: Stabilization(Months 3, 6, 9 and 12)
- Duration of Treatment(Baseline up to 28.4 months)
- Frequency of Macugen Administration(Baseline up to 28.4 months)
- Number of Participants Who Received Other Concomitant Age Related Macular Degeneration (AMD) Treatments(Months 3, 6, 9 and 12)