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临床试验/NCT02174211
NCT02174211已完成不适用

A Pharmacokinetic Study: Ranibizumab, Aflibercept and the Effect of Vitrectomy.

King's College Hospital NHS Trust1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物

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

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)

Active Comparator

Previous Vitrectomy

干预措施: Ranibizumab (Drug)

Arm B: Ranibizumab (Lucentis)

Active Comparator

Non-vitrectomised, PVD / no PVD

干预措施: Ranibizumab (Drug)

Arm C: Aflibercept (Eylea)

Active Comparator

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)

研究者

发起方
King's College Hospital NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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