NCT01988662已完成4 期
A 3 Months, patient-and Rater Blinded, Randomized, Prospective Study Comparing Systemic Anti-VEGF Effects Between Ranibizumab and Aflibercept in Treatment naïve Neovascular Age-related Macular Degeneration (nAMD) Patients
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 25
- 主要终点
- Percent Change From Baseline at Month 3 in Plasma VEGF Following Intravitreal (IVT) Injection of Anti-VEGF Agent
研究概览
简要总结
This study assessed systemic vascular endothelial growth factor (VEGF) level in patients with neovascular Age-related Macular Degeneration following treatment with Ranibizumab or Aflibercept.
Free plasma VEGF-A level was measured in this study .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •standard exclusion criteria for anti-VEGF treatment
- •Visual Acuity <6/96
- •nAMD in both eyes, or any condition in other eye which may have required anti- VEGF treatment during study period
- •other disease in candidate eye which could have compromised visual acuity or required medical/surgical intervention during study period
- •participation to other clinical study with 'not approved' treatment within a year prior to UNRAVEL study participation.
结局指标
主要结局
Percent Change From Baseline at Month 3 in Plasma VEGF Following Intravitreal (IVT) Injection of Anti-VEGF Agent
时间窗: Change from baseline at Month 3
Percent change in blood VEGF level is calculated as the difference in blood VEGF level measured after 3 month of anti-VEGF agent IVT treatment (Ranibizumab or Aflibercept) when compared to baseline blood VEGF level.
次要结局
- Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye Over Time(Baseline, month 1, month 2, month 3)
- Mean Change From Baseline in Central Retinal Thickness (CRT) of the Study Eye Over Time(Baseline, month 1, month 2, month 3)
- Percent Change From Baseline in Plasma VEGF Level Overtime(Change from baseline up to month 3)
- Correlation Between Percent Change From Baseline Plasma VEGF Level and the Serum Anti-VEGF Agent Overtime(pre-dose to post-dose at Baseline, week 1, week 2, month 1, month 2, and month 3)
- Number of Patients With Ocular and Systemic Adverse Events(Day 1 to day 85)
研究者
研究点 (25)
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