Blood Coagulation Parameters in Patients Receiving Intravitreal Aflibercept for Age-related Macular Degeneration
NCT ID: NCT03509623
Last Updated: 2018-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
47 participants
INTERVENTIONAL
2017-08-02
2018-04-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Blood coagulation and aflibercept
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
60 Years
ALL
No
Sponsors
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University Hospital of Patras
OTHER
Responsible Party
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Constantinos D. Georgakopoulos, MD, PhD
Associate Professor in Ophthalmology
Locations
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University Hospital of Patras
Pátrai, Achaia, Greece
Countries
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References
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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.
Other Identifiers
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516/26.7.2017
Identifier Type: -
Identifier Source: org_study_id
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