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

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?

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