Systemic Pharmacokinetics Following Intravitreal Injections of Anti-VEGF

April 13, 2016 updated by: California Retina Consultants

Systemic Pharmacokinetics Following Intravitreal Injections of Ranibizumab, Bevacizumab or Aflibercept in Patients With Neovascular Age-related Macular Degeneration

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aflibercept Blood Sample Collection
Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.
Biological: Blood Sample Collection
Subjects will have their blood drawn for analysis following their first and third injections of anti-VEGF.
Drug: Aflibercept
an intravitreal injection of Aflibercept administered three times on a monthly basis.
Other Names:
  • Eylea
Active Comparator: Bevacizumab Blood Sample Collection
Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.
Biological: Blood Sample Collection
Subjects will have their blood drawn for analysis following their first and third injections of anti-VEGF.
Drug: Bevacizumab
an intravitreal injection of Bevacizumab administered three times on a monthly basis.
Other Names:
  • Avastin
Active Comparator: Ranibizumab Blood Sample Collection
Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.
Biological: Blood Sample Collection
Subjects will have their blood drawn for analysis following their first and third injections of anti-VEGF.
Drug: Ranibizumab
an intravitreal injection of Ranibizumab administered three times on a monthly basis.
Other Names:
  • Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses
Time Frame: Up to 4 months
Maximum serum levels of ranibizumab, bevacizumab or aflibercept will be measured after the first and third injections, up to 28 days following each treatment.
Up to 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Minimum Serum Levels of Free Vascular Endothelial Growth Factor From Baseline to Month 4 (One Month After Last Treatment)
Time Frame: baseline and month 4
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).
baseline and month 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Retina Consultants

Investigators

  • Principal Investigator: Robert L Avery, MD, California Retina Consultants
  • Study Director: Melvin D Rabena, BS, California Retina Consultants

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

April 17, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Estimate)

May 19, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28032

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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