Inhibition of Proteinkinase C in the Treatment of Diabetic Macular Edema: Results of a Phase 2 Study
Kusserow C., Beckendorf A., Schmidt-Erfurth U. and the PKC Study Group
Department of Ophthalmology, Luebeck University
Purpose: Proteinkinase C (PKC) and vascular endothelial growth factor (VEGF) are important regulators of vascular permeability. A multi-center, placebo-controlled and double-masked study is used to evaluate the efficacy of an oral PKC-VEGF-inhibitor (PKC 412) in the treatment of clinically significant diabetic macular edema (CSME).
Method: A total of 141 patients with CSME were recruited by 12 retina referral centers world-wide. A controlled oral administration of PKC 412 was performed over a period of 3 months using 3 different dosage of 50, 100 and 150 mg of Verum as well as a placebo group. The efficacy of PKC 412 was documented based on changes in retinal thickening seen by stereoscopic fundus photography, by ETDRS visual tests, contrast sensitivity measurement and fluorescein angiography. Simultaneously, retinal thickness was regularly measured using the retinal thickness analyzer (RTA) and/or optical coherence tomography (OCT). Functional changes were documented by SLO-microperimetry. Safety and side-effects of the medication were controlled in an interdisciplinary approach. The results after 3 months of administration are presented.
Results: Retinal thickening (RT) was evaluated within 13 locations of the macular area. The area of greatest RT for all 13 locations combined, as seen by fundus photography, was significantly reduced at a dose of
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