Other Clinical Trial - Plasma Levels of Vascular Endothelial Growth Factor

Status Completed

Clinical Trial 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.

Clinical Trial 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? ;

Study Design

Related Conditions & MeSH terms

Exudative Age-related Macular Degeneration
Macular Degeneration
Wet Macular Degeneration

Clinical Trial Details

NCT number	NCT02125864
Study type	Interventional
Source	Oslo University Hospital
Contact
Status	Completed
Phase	Phase 4
Start date	April 2014
Completion date	November 2014

View Details

See also
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Completed	`NCT02355028` - LHA510 Proof-of-Concept Study as a Maintenance Therapy for Patients With Wet Age-Related Macular Degeneration	Phase 2
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Plasma Levels of Vascular Endothelial Growth Factor Before and After Intravitreal Injection of Aflibercept — Eylea-2014

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms