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
1 other identifier
interventional
47
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2018
CompletedFirst Submitted
Initial submission to the registry
April 4, 2018
CompletedFirst Posted
Study publicly available on registry
April 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2018
CompletedMay 7, 2018
April 1, 2018
8 months
April 4, 2018
May 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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
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
Study Arms (1)
Blood coagulation and aflibercept
EXPERIMENTALBlood 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.
Interventions
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
You may qualify if:
- treatment naive patients with neovascular AMD scheduled to undergo treatment with intravitreal aflibercept(IVA) in one eye.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Patras
Pátrai, Achaia, 26504, Greece
Related Publications (1)
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.
PMID: 32095777DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor in Ophthalmology
Study Record Dates
First Submitted
April 4, 2018
First Posted
April 26, 2018
Study Start
August 2, 2017
Primary Completion
March 26, 2018
Study Completion
April 27, 2018
Last Updated
May 7, 2018
Record last verified: 2018-04