Clinical trial NCT02125864: Plasma Levels of Vascular Endothelial Growth Factor Before and After Intravitreal Injection of Aflibercept
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Exudative Age-related Macular Degeneration
Keywords: AMD
VEGF
Aflibercept
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 16
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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?

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

Primary outcomes:
measure: Mean change in VEGF plasma concentration (pg/mL)
timeFrame: 6 months
Secondary outcomes:
measure: Mean change in Visual Acuity as measured with the Snellen chart
timeFrame: 6 months
measure: Central Retinal Thickness as measured by Optical coherence tomography expressed in microns
timeFrame: 6 months
measure: Number of non-responders
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
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.