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

NCT ID: NCT02125864

Last Updated: 2022-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-11-30

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?

Conditions

Exudative Age-related Macular Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Aflibercept

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

Group Type: EXPERIMENTAL

intravitreal injection

Intervention Type: PROCEDURE

collecting blood samples

Interventions

intravitreal injection

collecting blood samples

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

ANCA ROALD

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 25966740 (View on PubMed)

Other Identifiers

2014-000103-27

Identifier Type: -

Identifier Source: org_study_id