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Systemic Pharmacokinetics Following Intravitreal Injections of Anti-VEGF

Primary Purpose

Age-related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Blood Sample Collection
Aflibercept
Bevacizumab
Ranibizumab
Sponsored by
California Retina Consultants
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Age-related Macular Degeneration focused on measuring macular degeneration, diabetic macular edema, vein occlusion, vascular endothelial growth factor

Eligibility Criteria

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

Inclusion Criteria:

  • Ability to provide written informed consent for participation in this study
  • Subjects with a diagnosis of neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion who are either treatment naïve or more than 4 months out from a prior intravitreal anti-vascular endothelial growth factor injection

Exclusion Criteria:

  • Subjects unwilling to receive 3 monthly injections of anti-vascular endothelial growth factor as initial therapy
  • Subjects who may need or have received systemic anti-vascular endothelial growth factor for oncology in the past year
  • Subjects with history of another ocular disease other than neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion
  • Subjects with history of vitrectomy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Aflibercept Blood Sample Collection

    Bevacizumab Blood Sample Collection

    Ranibizumab Blood Sample Collection

    Arm Description

    Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.

    Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.

    Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.

    Outcomes

    Primary Outcome Measures

    Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses
    Maximum serum levels of ranibizumab, bevacizumab or aflibercept will be measured after the first and third injections, up to 28 days following each treatment.

    Secondary Outcome Measures

    Change in Minimum Serum Levels of Free Vascular Endothelial Growth Factor From Baseline to Month 4 (One Month After Last Treatment)
    Minimum serum levels of free vascular endothelial growth factor will be measured at baseline and at 4 months following treatment (one month after last treatment).

    Full Information

    First Posted
    April 15, 2014
    Last Updated
    April 13, 2016
    Sponsor
    California Retina Consultants
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02118831
    Brief Title
    Systemic Pharmacokinetics Following Intravitreal Injections of Anti-VEGF
    Official Title
    Systemic Pharmacokinetics Following Intravitreal Injections of Ranibizumab, Bevacizumab or Aflibercept in Patients With Neovascular Age-related Macular Degeneration
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2012 (undefined)
    Primary Completion Date
    February 2014 (Actual)
    Study Completion Date
    April 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    California Retina Consultants

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Comparable data for bevacizumab and aflibercept are lacking, as are studies comparing the systemic levels of ranibizumab, bevacizumab, and aflibercept and their relative effects on circulating vascular endothelial growth factor. In the present prospective study, the investigators evaluated serum drug levels and plasma free vascular endothelial growth factor (VEGF) levels in patients with neovascular age-related macular degeneration following intravitreal injections of ranibizumab, bevacizumab and aflibercept.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Age-related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
    Keywords
    macular degeneration, diabetic macular edema, vein occlusion, vascular endothelial growth factor

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    56 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Aflibercept Blood Sample Collection
    Arm Type
    Active Comparator
    Arm Description
    Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.
    Arm Title
    Bevacizumab Blood Sample Collection
    Arm Type
    Active Comparator
    Arm Description
    Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.
    Arm Title
    Ranibizumab Blood Sample Collection
    Arm Type
    Active Comparator
    Arm Description
    Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.
    Intervention Type
    Biological
    Intervention Name(s)
    Blood Sample Collection
    Intervention Description
    Subjects will have their blood drawn for analysis following their first and third injections of anti-VEGF.
    Intervention Type
    Drug
    Intervention Name(s)
    Aflibercept
    Other Intervention Name(s)
    Eylea
    Intervention Description
    an intravitreal injection of Aflibercept administered three times on a monthly basis.
    Intervention Type
    Drug
    Intervention Name(s)
    Bevacizumab
    Other Intervention Name(s)
    Avastin
    Intervention Description
    an intravitreal injection of Bevacizumab administered three times on a monthly basis.
    Intervention Type
    Drug
    Intervention Name(s)
    Ranibizumab
    Other Intervention Name(s)
    Lucentis
    Intervention Description
    an intravitreal injection of Ranibizumab administered three times on a monthly basis.
    Primary Outcome Measure Information:
    Title
    Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses
    Description
    Maximum serum levels of ranibizumab, bevacizumab or aflibercept will be measured after the first and third injections, up to 28 days following each treatment.
    Time Frame
    Up to 4 months
    Secondary Outcome Measure Information:
    Title
    Change in Minimum Serum Levels of Free Vascular Endothelial Growth Factor From Baseline to Month 4 (One Month After Last Treatment)
    Description
    Minimum serum levels of free vascular endothelial growth factor will be measured at baseline and at 4 months following treatment (one month after last treatment).
    Time Frame
    baseline and month 4

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ability to provide written informed consent for participation in this study Subjects with a diagnosis of neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion who are either treatment naïve or more than 4 months out from a prior intravitreal anti-vascular endothelial growth factor injection Exclusion Criteria: Subjects unwilling to receive 3 monthly injections of anti-vascular endothelial growth factor as initial therapy Subjects who may need or have received systemic anti-vascular endothelial growth factor for oncology in the past year Subjects with history of another ocular disease other than neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion Subjects with history of vitrectomy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert L Avery, MD
    Organizational Affiliation
    California Retina Consultants
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Melvin D Rabena, BS
    Organizational Affiliation
    California Retina Consultants
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25001321
    Citation
    Avery RL, Castellarin AA, Steinle NC, Dhoot DS, Pieramici DJ, See R, Couvillion S, Nasir MA, Rabena MD, Le K, Maia M, Visich JE. Systemic pharmacokinetics following intravitreal injections of ranibizumab, bevacizumab or aflibercept in patients with neovascular AMD. Br J Ophthalmol. 2014 Dec;98(12):1636-41. doi: 10.1136/bjophthalmol-2014-305252. Epub 2014 Jul 7.
    Results Reference
    derived

    Learn more about this trial

    Systemic Pharmacokinetics Following Intravitreal Injections of Anti-VEGF

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