Systemic Pharmacokinetics Following Intravitreal Injections of Ranibizumab, Bevacizumab or Aflibercept in Patients With Neovascular Age-related Macular Degeneration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 主要终点
- Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses
研究概览
简要总结
Comparable data for bevacizumab and aflibercept are lacking, as are studies comparing the systemic levels of ranibizumab, bevacizumab, and aflibercept and their relative effects on circulating vascular endothelial growth factor. In the present prospective study, the investigators evaluated serum drug levels and plasma free vascular endothelial growth factor (VEGF) levels in patients with neovascular age-related macular degeneration following intravitreal injections of ranibizumab, bevacizumab and aflibercept.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent for participation in this study
- •Subjects with a diagnosis of neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion who are either treatment naïve or more than 4 months out from a prior intravitreal anti-vascular endothelial growth factor injection
排除标准
- •Subjects unwilling to receive 3 monthly injections of anti-vascular endothelial growth factor as initial therapy
- •Subjects who may need or have received systemic anti-vascular endothelial growth factor for oncology in the past year
- •Subjects with history of another ocular disease other than neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion
- •Subjects with history of vitrectomy
研究组 & 干预措施
Ranibizumab Blood Sample Collection
Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.
干预措施: Ranibizumab (Drug)
Aflibercept Blood Sample Collection
Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.
干预措施: Blood Sample Collection (Biological)
Aflibercept Blood Sample Collection
Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.
干预措施: Aflibercept (Drug)
Bevacizumab Blood Sample Collection
Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.
干预措施: Blood Sample Collection (Biological)
Bevacizumab Blood Sample Collection
Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.
干预措施: Bevacizumab (Drug)
Ranibizumab Blood Sample Collection
Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.
干预措施: Blood Sample Collection (Biological)
结局指标
主要结局
Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses
时间窗: Up to 4 months
Maximum serum levels of ranibizumab, bevacizumab or aflibercept will be measured after the first and third injections, up to 28 days following each treatment.
次要结局
- Change in Minimum Serum Levels of Free Vascular Endothelial Growth Factor From Baseline to Month 4 (One Month After Last Treatment)(baseline and month 4)