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

U

University Hospital of Patras

Status

Completed

Conditions

Neovascular Age-related Macular Degeneration

Treatments

Diagnostic Test: Blood sampling through direct peripheral venous puncture

Study type

Interventional

Funder types

Other

Identifiers

NCT03509623
516/26.7.2017

Details and patient eligibility

About

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 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.

Enrollment

47 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

47 participants in 1 patient group

Blood coagulation and aflibercept
Experimental group
Description:
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.
Treatment:
Diagnostic Test: Blood sampling through direct peripheral venous puncture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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