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Impressum
Proteinkinase C (PKC) - and vascular endothelial growth factor- (VEGF) inhibition in diabetic maculopathy
Beckendorf A., Kusserow C., Schmidt-Erfurth U.
Klinik für Augenheilkunde, Universitätsklinikum Lübeck, Ratzeburger Allee 160, 23538 Lübeck
Background: Exudative diabetic maculopathy (DMP) is the consequence
of an alteration of the retinal vascular barrier with pathological permeability
and extravasation of blood components. Proteinkinase C (PKC) and vascular
endothelial growth factor (VEGF) were identified as important mediators
of vascular permeability and are responsible for a break-down of the blood-retina
barrier in a vasoocclusive and ischemic situation. The pharmacological
inhibition of these factors was found to restore the vascular barrier
function with a resolution of exudation experimentally.
Methods: In a multi-center, randomized, double-masked clinical
trial phase II efficacy and safety of the systemic administration of a
PKC / VEGF inhibitor are evaluated. Patients with clinically significant
macular edema (CSME) are treated with placebo or two different dose regimen
of the compound. Primary study aim is a significant reduction of the CSME
area based on the stereoscopic evaluation of the retina by an independent
reading center.
Results: 24 patients with CSME due to diabetes mellitus I/II were
included into the study in a single retina referral center. All participants
received either placebo (n=8) or verum (n=16) during an interval of 3
months. No event of discontinuation of the study medication due to side-effects
was documented. Neither had the study to be terminated due to a massive
progression of retinal exudation. In a subgroup of patients an increase
in central visual acuity according to ETDRS-criteria, a decrease in central
retinal thickness (retinal thickness analyzer) and a resolution of central
functional defects (scanning laser scotometry) were detected.
Conclusion: The inhibition of vascular permeability factors in
exudative DMP offers a promising concept for a selective and causative
treatment of diabetic vasculopathy. The systemic application appears to
be safe and not associated with general or ocular side-effects.