- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03509623
Blood Coagulation Parameters in Patients Receiving Intravitreal Aflibercept for Age-related Macular Degeneration
Effect of Intravitreal Injection of Aflibercept on Blood Coagulation Parameters in Patients With Age Related Macular Degeneration
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Achaia
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Patra, Achaia, Greece, 26504
- University Hospital of Patras
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
|
Change in Plasma fibrinogen levels
Time Frame: Samples will be received before the first intravitreal injection, at 7 and 30 days after aflibercept administration
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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
Time Frame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
|
Peripheral blood sample analysis
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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)
Time Frame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
|
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)
Time Frame: Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
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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)
Time Frame: Samples will be received before the first intravitreal injection,at 7 and at 30 days after aflibercept administration
|
Peripheral blood sample analysis
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Samples will be received before the first intravitreal injection,at 7 and at 30 days after aflibercept administration
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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
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Peripheral blood sample analysis
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Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
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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
|
Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 516/26.7.2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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