Effect of Intravitreal Injection of Aflibercept on Blood Coagulation Parameters in Patients With Age Related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Change in Platelet count
研究概览
简要总结
This study aims to evaluate coagulation parameters in treatment naive patients with neovascular age-related macular degeneration (AMD). Treatment naive patients with neovascular AMD, scheduled to undergo treatment with intravitreal injections of aflibercept will be enrolled in the study. Blood samples will be collected before the first intravitreal injection and at 7 and 30 days after aflibercept administration.
详细描述
Neovascular age-related macular degeneration is one of the leading causes of severe visual loss in the aging population. Intravitreal anti-VEGF agents constitute the mainstay in the treatment of neovascular AMD.
Aflibercept is a recombinant fusion protein targeting vascular endothelial growth factor A(VEGF A) and placenta growth factor (PlGF), developed for intravitreal administration in conditions such as neovascular age related macular degeneration, macular edema due to retinal vein occlusion, diabetic macular edema or myopic choroidal neovascularization. However, treatment with anti-VEGFs like aflibercept, carries a potential risk of arterial thromboembolic events, including stroke and myocardial infarction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •treatment naive patients with neovascular AMD scheduled to undergo treatment with intravitreal aflibercept(IVA) in one eye.
排除标准
- •patients under systemic treatment with anti-VEGF agents
- •patients under intravitreal anti-VEGF treatment in both eyes
- •patients unwilling to return 1 week and 1 month after the first IVA
- •patients undergoing dialysis, with chronic liver disease or malignancy, under systemic treatment with nonsteroidal anti-inflammatory drugs or under anticoagulation therapy
- •patients with a history of any ATE event during the last 6 months
结局指标
主要结局
Change in Platelet count
时间窗: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Peripheral blood sample analysis
Change in Plasma D-dimer levels
时间窗: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Peripheral blood sample analysis
Change in Plasma fibrinogen levels
时间窗: Samples will be received before the first intravitreal injection, at 7 and 30 days after aflibercept administration
Peripheral blood sample analysis
Change in Activated partial thromboplastin time (aPTT)
时间窗: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Peripheral blood sample analysis
Change in Prothrombin time (PT)
时间窗: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Peripheral blood sample analysis
Change in Protein C levels
时间窗: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Peripheral blood sample analysis
Change in International normalized ratio (INR)
时间窗: Samples will be received before the first intravitreal injection,at 7 and at 30 days after aflibercept administration
Peripheral blood sample analysis
Change in Protein S levels
时间窗: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Peripheral blood sample analysis
次要结局
未报告次要终点
研究者
Constantinos D. Georgakopoulos, MD, PhD
Associate Professor in Ophthalmology
University Hospital of Patras