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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood coagulation and aflibercept | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling through direct peripheral venous puncture | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Change in Protein S levels | Peripheral blood sample analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Patras | Pátrai | Achaia | 26504 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32095777 | Derived | Georgakopoulos CD, Makri OE, Pallikari A, Kagkelaris K, Plotas P, Grammenou V, Emmanuil A. Effect of intravitreal injection of aflibercept on blood coagulation parameters in patients with age-related macular degeneration. Ther Adv Ophthalmol. 2020 Feb 11;12:2515841420903929. doi: 10.1177/2515841420903929. eCollection 2020 Jan-Dec. |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration |
| 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 |