The Effect of Ruboxistaurin on Visual Loss in Patients with Moderately Severe To Very Severe Nonproliferative Diabetic Retinopathy: Initial Results of The Protein Kinase C Beta Inhibitor Diabetic Retinopathy Study (PKC-DRS) Multicenter Randomized Clinical

Publication Type
Journal Article
Year of Publication
2005
Authors
The PKC-DRS Study Group
Secondary
Diabetes
Volume
54
Start Page
2188
Pagination
2188-2197
Date Published
07/2005
Keywords
Adult; Aged; Diabetic Retinopathy; Disease Progression; Enzyme Inhibitors; Female; Indoles; Male; Maleimides; Middle Aged; Patient Selection; Placebos; Protein Kinase C; ruboxistaurin; Treatment Outcome; Vision Disorders
ISBN
00121797
Abstract
{The purpose of this study was to evaluate the Safety and efficacy of the orally administered protein kinase C (PKC) beta isoform-selective inhibitor ruboxistaurin (RBX) in subjects with moderately severe to very severe nonproliferative diabetic retinopathy (NPDR). In this multicenter, double-masked, randomized, placebo-controlled study, 252 subjects received placebo or RBX (8, 16, or 32 mg/day) for 36-46 months. Patients had an Early Treatment Diabetic Retinopathy Study (ETDRS) retinopathy severity level between 47B and 53E inclusive, an ETDRS visual acuity of 20/125 or better, and no history of scatter (panretinal) photocoagulation. Efficacy measures included progression of DR, moderate visual loss (MVL) (doubling of the visual angle), and sustained MVL (SMVL). RBX was well tolerated without significant adverse effects but had no significant effect on the progression of DR. Compared with placebo, 32 mg/day RBX was associated with a delayed occurrence of MVL (log rank