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Inhibition of Protein Kinase C and Vascular Endothelial Growth Factor in Diabetes Induced Clinically Significant Macular Edema
Beckendorf A., Michels S., Müller-Velten R., Schmidt-Erfurth U.,
Medizinische Universität zu Lübeck, Klinik für Augenheilkunde (Lübeck)
Purpose: Treatment of clinically significant macular edema (CSME) due to diabetes is not yet satisfactory. Proteinkinase C (PKC) and vascular endothelial growth factor (VEGF) are of major importance for vascular permeability. PKC 412 is an inhibitor of PKC as well as the receptor-bound tyrosinkinase of VEGF. An international, placebo controlled and double-masked study was designed to evaluate the efficacy of oral administration of PKC 412 in the treatment of diabetic CSME.
Method: A total number of 136 patients was recruited by 12 tertial referral centers. 27 patients in Luebeck. Patients were randomized to three dosage regimen of medication and one placebo group and received a controlled oral drug administration over a three month interval. Ocular efficacy of PKC 412 intake was documented by ETDRS visual acuity and Pelli Robson contrast sensitivity tests, functional evaluation using SLO microperimetry and measurements of retinal thickness using a retinal thickness analyzer (RTA) and optical coherence tomography (OCT) as well as regular stereoscopic fundus photography evaluated by an independent reading center. The spectrum of potential side-effects was documented in an interdisciplinary approach.
Results: Patient recruitment was successfully terminated in 05/2000. After completion of a 6 month follow-up interval following drug discontinuation results indicated a reduction in central retinal thickness and resolution of retinal functional defects in an subgroup of patients. Few patients demonstrated further progression of diabetic maculopathy. The majority of patients presented with stabilization of their retinal status. Quantitative results following data analysis after 9 months follow-up will be presented. Discontinuation due to drug-related side-effects was not required.
Conclusions: Pharmacologic therapentical approaches in diabetic macular disease appear to offer promising alternatives compared to laser coagulation due to their non invasive mechanism. Systemic side-effects were not significant in the treatment with PKC/VEGF inhibition.