A Pharmacokinetic Study: Ranibizumab, Aflibercept and the Effect of Vitrectomy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Ranibizumab half-life
研究概览
简要总结
To study the effect of pars plana vitrectomy on the intravitreal pharmacokinetics of ranibizumab and to compare the half-life of ranibizumab and aflibercept.
详细描述
This study is a prospective, pharmacokinetic study comparing ranibizumab clearance in two groups of patients; those with and without prior vitrectomy. Additionally it will compare ranibizumab clearance to aflibercept clearance as well as the effect on systemic circulating inflammatory and safety markers. Patients will already be receiving ranibizumab or aflibercept therapy - the injection is itself administered irrespective of their participation in this study and therefore this study will not alter medical management or the choice of therapy.
To estimate ranibizumab and aflibercept clearance, it is important to measure serum concentrations at several intervals within the first 24 hours. Participants will ideally have venous blood sampling at the following times after their ranibizumab or aflibercept injection:
- 1 hour
- 2 hours
- 3 hours
- 4 hours
- 6 hours
- 24 hours
- 2 days
- 4 days
- 1 week*
- 2 weeks
- 4 weeks*
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 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
- 未提供
研究组 & 干预措施
Arm A: Ranibizumab (Lucentis)
Previous Vitrectomy
干预措施: Ranibizumab (Drug)
Arm B: Ranibizumab (Lucentis)
Non-vitrectomised, PVD / no PVD
干预措施: Ranibizumab (Drug)
Arm C: Aflibercept (Eylea)
Non-vitrectomised, PVD / no PVD
干预措施: Aflibercept (Drug)
结局指标
主要结局
Ranibizumab half-life
时间窗: 12 Months
Vitrectomised and non-vitrectomised patients
Aflibercept half-life
时间窗: 12 Months
Non-vitrectomised patients only
次要结局
- Sub-group analysis of the effect of PVD on ranibizumab half-life(12 months)
- The effect of ranibizumab and aflibercept concentrations on serum inflammatory and safety marker levels.(12 months)
