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

NCT02125864 | Completed Phase 4 DMC

• 1 other identifier: 2014-000103-27
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Exudative Age-related Macular Degeneration

Keywords

AMD; VEGF; Aflibercept

Outcome Measures

Primary Outcomes (1)

• Mean change in VEGF plasma concentration (pg/mL)

  6 months

Secondary Outcomes (3)

• Mean change in Visual Acuity as measured with the Snellen chart

  6 months

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

  6 months

• Number of non-responders

  6 months

Study Arms (1)

Aflibercept

EXPERIMENTAL

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

Procedure: intravitreal injection

Interventions

intravitreal injection PROCEDURE

collecting blood samples

Aflibercept

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Related Publications (1)

• 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.

  PMID: 25966740 DERIVED

MeSH Terms

Interventions

Intravitreal Injections

Intervention Hierarchy (Ancestors)

Injections, Intraocular; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 29, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 27, 2022

Record last verified: 2022-04