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

Primary Purpose

Exudative Age-related Macular Degeneration

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

intravitreal injection

About this trial

This is an interventional basic science trial for Exudative Age-related Macular Degeneration focused on measuring AMD, VEGF, Aflibercept

Eligibility Criteria

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aflibercept

Arm Description

There is only one arm. Plasma VEGF is investigated in the same patient before and after intravitreal Aflibercept injection.

Outcomes

Primary Outcome Measures

Mean change in VEGF plasma concentration (pg/mL)

Secondary Outcome Measures

Mean change in Visual Acuity as measured with the Snellen chart

Central Retinal Thickness as measured by Optical coherence tomography expressed in microns

Number of non-responders

Full Information

NCT ID

NCT02125864

First Posted

April 24, 2014

Last Updated

April 19, 2022

Sponsor

Oslo University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02125864

Brief Title

Plasma Levels of Vascular Endothelial Growth Factor Before and After Intravitreal Injection of Aflibercept

Acronym

Eylea-2014

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

April 2014 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Exudative Age-related Macular Degeneration

Keywords

AMD, VEGF, Aflibercept

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aflibercept

Arm Type

Experimental

Arm Description

There is only one arm. Plasma VEGF is investigated in the same patient before and after intravitreal Aflibercept injection.

Intervention Type

Procedure

Intervention Name(s)

intravitreal injection

Intervention Description

collecting blood samples

Primary Outcome Measure Information:

Title

Mean change in VEGF plasma concentration (pg/mL)

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Mean change in Visual Acuity as measured with the Snellen chart

Time Frame

6 months

Title

Central Retinal Thickness as measured by Optical coherence tomography expressed in microns

Time Frame

6 months

Title

Number of non-responders

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Citations:

PubMed Identifier

25966740

Citation

Roald AB, Aass HC, Moe MC. Recovery of plasma vascular endothelial growth factor concentrations during aflibercept loading phase and after the transition to bimonthly treatment for neovascular age-related macular degeneration. Br J Ophthalmol. 2015 Dec;99(12):1610-3. doi: 10.1136/bjophthalmol-2015-306781. Epub 2015 May 12.

Results Reference

derived

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Plasma Levels of Vascular Endothelial Growth Factor Before and After Intravitreal Injection of Aflibercept

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