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

May 4, 2018 updated by: Constantinos D. Georgakopoulos, MD, PhD, University Hospital of Patras

Effect of Intravitreal Injection of Aflibercept on Blood Coagulation Parameters in Patients With 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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Achaia
      • Patra, Achaia, Greece, 26504
        • University Hospital of Patras

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
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
Samples will be received before the first intravitreal injection, at 7 and 30 days after aflibercept administration
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
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)
Time Frame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
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)
Time Frame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
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)
Time Frame: Samples will be received before the first intravitreal injection,at 7 and at 30 days after aflibercept administration
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
Time Frame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
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
Time Frame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Peripheral blood sample analysis
Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2017

Primary Completion (Actual)

March 26, 2018

Study Completion (Actual)

April 27, 2018

Study Registration Dates

First Submitted

April 4, 2018

First Submitted That Met QC Criteria

April 25, 2018

First Posted (Actual)

April 26, 2018

Study Record Updates

Last Update Posted (Actual)

May 7, 2018

Last Update Submitted That Met QC Criteria

May 4, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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