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Blood Coagulation Parameters in Patients Receiving Intravitreal Aflibercept for Age-related Macular Degeneration

Primary Purpose

Neovascular Age-related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Blood sampling through direct peripheral venous puncture
Sponsored by
University Hospital of Patras
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Neovascular Age-related Macular Degeneration focused on measuring neovascular age-related macular degeneration, aflibercept, intravitreal anti-VEGF, coagulation, platelet count, D-Dimer, Fibrinogen

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Patras

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blood coagulation and aflibercept

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Platelet count
Peripheral blood sample analysis
Change in Plasma fibrinogen levels
Peripheral blood sample analysis
Change in Plasma D-dimer levels
Peripheral blood sample analysis
Change in Activated partial thromboplastin time (aPTT)
Peripheral blood sample analysis
Change in Prothrombin time (PT)
Peripheral blood sample analysis
Change in International normalized ratio (INR)
Peripheral blood sample analysis
Change in Protein S levels
Peripheral blood sample analysis
Change in Protein C levels
Peripheral blood sample analysis

Secondary Outcome Measures

Full Information

First Posted
April 4, 2018
Last Updated
May 4, 2018
Sponsor
University Hospital of Patras
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1. Study Identification

Unique Protocol Identification Number
NCT03509623
Brief Title
Blood Coagulation Parameters in Patients Receiving Intravitreal Aflibercept for Age-related Macular Degeneration
Official Title
Effect of Intravitreal Injection of Aflibercept on Blood Coagulation Parameters in Patients With Age Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2, 2017 (Actual)
Primary Completion Date
March 26, 2018 (Actual)
Study Completion Date
April 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Patras

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration
Keywords
neovascular age-related macular degeneration, aflibercept, intravitreal anti-VEGF, coagulation, platelet count, D-Dimer, Fibrinogen

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blood coagulation and aflibercept
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood sampling through direct peripheral venous puncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Platelet count
Description
Peripheral blood sample analysis
Time Frame
Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Title
Change in Plasma fibrinogen levels
Description
Peripheral blood sample analysis
Time Frame
Samples will be received before the first intravitreal injection, at 7 and 30 days after aflibercept administration
Title
Change in Plasma D-dimer levels
Description
Peripheral blood sample analysis
Time Frame
Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Title
Change in Activated partial thromboplastin time (aPTT)
Description
Peripheral blood sample analysis
Time Frame
Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Title
Change in Prothrombin time (PT)
Description
Peripheral blood sample analysis
Time Frame
Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Title
Change in International normalized ratio (INR)
Description
Peripheral blood sample analysis
Time Frame
Samples will be received before the first intravitreal injection,at 7 and at 30 days after aflibercept administration
Title
Change in Protein S levels
Description
Peripheral blood sample analysis
Time Frame
Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration
Title
Change in Protein C levels
Description
Peripheral blood sample analysis
Time Frame
Samples will be received before the first intravitreal injection, at 7 and at 30 days after aflibercept administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital of Patras
City
Patra
State/Province
Achaia
ZIP/Postal Code
26504
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
32095777
Citation
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.
Results Reference
derived

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Blood Coagulation Parameters in Patients Receiving Intravitreal Aflibercept for Age-related Macular Degeneration

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