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

Overview

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.

Full Title of Study: “Effect of Intravitreal Injection of Aflibercept on Blood Coagulation Parameters in Patients With Age Related Macular Degeneration”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 26, 2018

Detailed Description

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.

Interventions

  • Diagnostic Test: Blood sampling through direct peripheral venous puncture
    • 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.

Arms, Groups and Cohorts

  • Experimental: Blood coagulation and aflibercept
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Platelet count
    • Time Frame: 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
    • Time Frame: Samples will be received before the first intravitreal injection, at 7 and 30 days after aflibercept administration
    • Peripheral blood sample analysis
  • Change in Plasma D-dimer levels
    • Time Frame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
    • Peripheral blood sample analysis
  • Change in Activated partial thromboplastin time (aPTT)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
    • Peripheral blood sample analysis

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital of Patras
  • Provider of Information About this Clinical Study
    • Principal Investigator: Constantinos D. Georgakopoulos, MD, PhD, Associate Professor in Ophthalmology – University Hospital of Patras

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