Blood Coagulation Parameters in Patients Receiving Intravitreal Aflibercept for Age-related Macular Degeneration

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Intravitreal Injection of Aflibercept on Blood Coagulation Parameters in Patients With Age Related Macular Degeneration

Conditions
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Neovascular Age-related Macular Degeneration

Intervention / Treatment
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* Diagnostic Test: Blood sampling through direct peripheral venous puncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: treatment naive patients with neovascular AMD scheduled to undergo treatment with intravitreal aflibercept(IVA) in one eye. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood coagulation and aflibercept<br>Blood sampling through direct peripheral venous puncture will be collected from treatment naive patients commencing treatment with intravitreal injections of aflibercept for neovascular AMD before the first intravitreal injection of aflibercept and at 7 and 30 days post-injection. Blood coagulation parameters will be evaluated at each timepoint. | Diagnostic Test: Blood sampling through direct peripheral venous puncture<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Platelet count | Peripheral blood sample analysis | 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 | 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 | 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 | 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 | 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 | 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 | Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration | 
| Change in Protein C levels | Peripheral blood sample analysis | Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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D-Dimer, neovascular age-related macular degeneration, aflibercept, intravitreal anti-VEGF, coagulation, platelet count, Fibrinogen