Effect of Intravitreal Injection of Aflibercept on Blood Coagulation Parameters in Patients With Age Related Macular Degeneration
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neovascular Age-related Macular Degeneration
- Sponsor
- University Hospital of Patras
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Change in Platelet count
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Constantinos D. Georgakopoulos, MD, PhD
Associate Professor in Ophthalmology
University Hospital of Patras
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
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
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
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
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
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
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
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