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

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03509623
• Other study ID #: 516/26.7.2017
• Status: Completed
• Phase: N/A
• Start date: August 2, 2017
• Est. completion date: April 27, 2018

Study information

• Verified date: April 2018
• Source: University Hospital of Patras
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: April 27, 2018
• Est. primary completion date: March 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

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.

Locations

Country	Name	City	State
Greece	University Hospital of Patras	Patra	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Platelet count	Peripheral blood sample analysis	Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Primary	Change in Plasma fibrinogen levels	Peripheral blood sample analysis	Samples will be received before the first intravitreal injection, at 7 and 30 days after aflibercept administration
Primary	Change in Plasma D-dimer levels	Peripheral blood sample analysis	Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Primary	Change in Activated partial thromboplastin time (aPTT)	Peripheral blood sample analysis	Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Primary	Change in Prothrombin time (PT)	Peripheral blood sample analysis	Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Primary	Change in International normalized ratio (INR)	Peripheral blood sample analysis	Samples will be received before the first intravitreal injection,at 7 and at 30 days after aflibercept administration
Primary	Change in Protein S levels	Peripheral blood sample analysis	Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Primary	Change in Protein C levels	Peripheral blood sample analysis	Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration