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

Not Applicable

Completed

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Diagnostic Test: Blood sampling through direct peripheral venous puncture

• Registration Number: NCT03509623
• Lead Sponsor: University Hospital of Patras

Brief Summary

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

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 Timeline

• Study Start: 2017-08-02
• Primary Completion: 2018-03-26
• Status Verified: 2018-04
• Study First Submitted: 2018-04-04
• Study First Submitted QC: 2018-04-25
• Study First Posted: 2018-04-26
• Study Completion: 2018-04-27
• Last Update Submitted: 2018-05-04
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood coagulation and aflibercept	Blood sampling through direct peripheral venous puncture	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Patras; 🇬🇷 Patra, Achaia, Greece