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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
47
Fasting blood samples will be collected 10-15 minutes before the first intravitreal injection of aflibercept and at 7 and 30 days post-injection using a 19-gauge needle under minimum stasis. Blood coagulation parameters will be evaluated.
University Hospital of Patras
Pátrai, Achaia, Greece
Change in Platelet count
Peripheral blood sample analysis
Time frame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Change in Plasma fibrinogen levels
Peripheral blood sample analysis
Time frame: Samples will be received before the first intravitreal injection, at 7 and 30 days after aflibercept administration
Change in Plasma D-dimer levels
Peripheral blood sample analysis
Time frame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Change in Activated partial thromboplastin time (aPTT)
Peripheral blood sample analysis
Time frame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Change in Prothrombin time (PT)
Peripheral blood sample analysis
Time frame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Change in International normalized ratio (INR)
Peripheral blood sample analysis
Time frame: Samples will be received before the first intravitreal injection,at 7 and at 30 days after aflibercept administration
Change in Protein S levels
Peripheral blood sample analysis
Time frame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
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Change in Protein C levels
Peripheral blood sample analysis
Time frame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration