Plasma Levels of Vascular Endothelial Growth Factor Before and After Intravitreal Injection of Aflibercept (Eylea-2014)

April 19, 2022 updated by: ANCA ROALD, Oslo University Hospital

Plasma Levels of Vascular Endothelial Growth Factor Before and After Intravitreal Injection of Aflibercept in Patients With Exudative Age-related Macular Degeneration

The purpose of this study is to examine the plasma concentration of vascular endothelial growth factor (VEGF) after standard treatment with one of the newest growth factor inhibitors, aflibercept (Eylea).

Patients with exudative age-related macular degeneration (AMD) are treated today with anti-growth factors (anti-VEGF). Eylea appears to have a longer duration of action in the eye and a more powerful effect on the edema in the macula than previously used growth factor inhibitors. This means that the disease can be controlled with fewer number of injections into the eye and the investigators can therefore reduce the risk of complications associated with this type of treatment.

It is unclear what the plasma VEGF concentration after treatment with Eylea into the eye in patients with wet age-related macular degeneration is.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Macular edema secondary to exudative age-related macular degeneration is treated today primarily with vascular endothelial growth factor inhibitors, anti-VEGF.

There are currently four anti-VEGF drugs that are either approved or off-label used in ophthalmology. Pegaptanib (Macugen, Pfizer), ranibizumab (Lucentis, Novartis) aflibercept (Eylea, Bayer) and bevacizumab Avastin, Roche) . They have different molecules and pharmacodynamics .

VEGF plays an important role in many physiological and pathophysiological mechanisms. Studies have shown that even low-dose intravitreal treatment with bevacizumab leads to significant reduction of VEGF plasma concentration up to a month after treatment in patients with exudative AMD.

No significant systemic effect could be detected after intravitreal administration of ranibizumab or pegaptanib.

The purpose of this study is :

  • To determine if intravitreal treatment with Eylea affects VEGF plasma levels in patients with exudative AMD
  • How long after intravitreal injection is VEGF plasma concentration affected?

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 4

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women with exudative AMD
  • Central Retinal Thickness ≥ 250 microns
  • Best corrected visual acuity 20/25-20/320
  • Age ≥ 60 years
  • Only one eye will be applicable for recruitment
  • Informed signed consent according to International Conference on Harmonisation Good Clinical Practice should be in place prior to study .

Exclusion Criteria:

  • Bilateral disease
  • Treatment with intravitreal injections in the past three months
  • Patients who have previously undergone vitrectomy
  • Choroidal neovascular membrane secondary to other disease than AMD
  • Macula edema of other etiology than wet AMD
  • Intraocular pressure ≥ 30 mmHg in mydriasis
  • Active uveitis or infectious condition in the study eye
  • Patients using systemic anti inflammatory therapy ( steroids)
  • Patients using systemic anti-VEGF treatment
  • Blod pressure which is not well regulated
  • Dialysis or in need of transplantation resulting from renal failure
  • Heart attack, stroke, transient ischemic attack in the last 6 months
  • New York Heart Association class II , III , IV
  • Known allergy to aflibercept , fluorescein or povidone iodine
  • Unable to follow the study procedures

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aflibercept
There is only one arm. Plasma VEGF is investigated in the same patient before and after intravitreal Aflibercept injection.
Procedure: intravitreal injection
collecting blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in VEGF plasma concentration (pg/mL)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change in Visual Acuity as measured with the Snellen chart
Time Frame: 6 months
6 months
Central Retinal Thickness as measured by Optical coherence tomography expressed in microns
Time Frame: 6 months
6 months
Number of non-responders
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Oslo University Hospital

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

April 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

April 24, 2014

First Submitted That Met QC Criteria

April 26, 2014

First Posted (Estimate)

April 29, 2014

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-000103-27

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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