Neovascular Age-related Macular Degeneration
Conditions
Keywords
neovascular age-related macular degeneration, aflibercept, intravitreal anti-VEGF, coagulation, platelet count, D-Dimer, Fibrinogen
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.
Interventions
DIAGNOSTIC_TESTBlood 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.
Sponsors
University Hospital of Patras
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 |
| 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 |
Countries
Greece
Outcome results
None listed