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Diabetic Retinopathy Highlights from Retina/Vitreous Free Papers
Effect of Ruboxistaurin on Reversibility of Vision Loss in Patients with Nonproliferative Diabetic Retinopathy
| Sunday, November 12, 2006 |
| Ronald Peter Danis, MD, Matthew J Sheetz, MD, PhD, Lloyd P Aiello, MD, PhD, Matthew D Davis, MD, Roy C Milton, PhD, Aniz Girach, MBChB, Xin Zhi, PhD, Louis Vignati, MD, PKC-DRS2 Study Group
The Protein Kinase C-Diabetic Retinopathy Study 2 (PKC-DRS2), also known as the MCBM study, was a randomized, controlled, multicenter study of 685 patients with nonproliferative diabetic retinopathy (NPDR) treated with 32 mg/day ruboxistaurin (RBX) or placebo conducted over 36 months. Most patients had 2 eligible eyes, and about 25% of eyes had clinically significant macular edema. The purpose of the study was to assess the incidence of moderate visual loss (MVL), a loss of 7-15 Early Treatment of Diabetic Retinopathy Study letters sustained for 6 months (SMVL) at 3 years of study participation.
Patients treated with 32 mg RBX reduced the risk of SMVL by 40% (RBX: 5.5%, placebo: 9.1%, P=.034). Among patients with MVL at any single visit before year 2, 16.4% of patients treated with RBX and 30.8% of patients treated with placebo progressed to SMVL at year 3. SMVL at year 2 predicted continued SMVL at year 3 (RBX: 64.0%, placebo: 66.7%, P=.864). These findings suggest that once SMVL develops, further treatment with RBX will not reverse it. Fluctuations in visual acuity are common in trials of retinal diseases. SMVL is a more durable measure of vision loss than MVL. RBX reduced SMVL at 3 years in patients with NPDR.
Dr Aiello agreed that vision fluctuation occurred in diabetes. Dr Spaide noted that vision loss must be present on 2 consecutive office visits to differentiate sustained changes in visual acuity from typical fluctuations. |
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