Plasma Levels of Vascular Endothelial Growth Factor Before and After Intravitreal Injection of Aflibercept (Eylea-2014)
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|ClinicalTrials.gov Identifier: NCT02125864|
Recruitment Status : Completed
First Posted : April 29, 2014
Last Update Posted : January 21, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Exudative Age-related Macular Degeneration||Drug: Aflibercept||Phase 4|
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?
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|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 Start Date :||April 2014|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
- Mean change in VEGF plasma concentration (pg/mL) [ Time Frame: 6 months ]
- Mean change in Visual Acuity as measured with the Snellen chart [ Time Frame: 6 months ]
- Central Retinal Thickness as measured by Optical coherence tomography expressed in microns [ Time Frame: 6 months ]
- Number of non-responders [ Time Frame: 6 months ]