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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 24
- 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
- •Newly diagnosed Age-related Macular Degeneration (AMD)
- •No previous treatment received for diagnosed AMD
- •Visual Acuity 6/7.5 to 6/96
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.
研究组 & 干预措施
Ranibizumab
104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection adminstered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
干预措施: Neovascular Age-related Macular Degeneration (Procedure)
Aflibercept
101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection admistered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
干预措施: Neovascular Age-related Macular Degeneration (Procedure)
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)