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Completed

NCT Number: NCT03509623

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

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.

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Key information

Conditions

Neovascular Age-related Macular Degeneration Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Patras

Pátrai, Achaia, 26504, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling through direct peripheral venous puncture

Diagnostic Test

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

University Hospital of Patras

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 26, 2018
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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