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

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Treatments: Aflibercept; Endothelial Growth Factors; Mitogens

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