Abstract | OBJECTIVE: DESIGN: Thirty-six-month, randomized, double-masked, placebo-controlled, parallel, multicenter trial. PARTICIPANTS: Six hundred eighty-five patients randomized at 70 clinical sites. METHODS: Ophthalmologic examination was performed at screening and at each 3-month visit. Retinopathy status was assessed every 6 months with Early Treatment Diabetic Retinopathy Study (ETDRS) standard 7-field 30 degrees color stereoscopic fundus photography. Levels of diabetic retinopathy and diabetic macular edema were determined by 2 independent graders masked to site and treatment assignment, with additional independent adjudication as required. Eligible patients had a best-corrected visual acuity (VA) score of > or =45 letters, retinopathy level > or = 47A and < or = 53E, and no prior panretinal photocoagulation in at least one eye. MAIN OUTCOME MEASURE: Effect of oral ruboxistaurin (32 mg/day) on reduction of sustained moderate visual loss (> or =15-letter decrease in ETDRS VA score maintained > or = 6 months) in patients with moderately severe to very severe nonproliferative diabetic retinopathy. RESULTS: Sustained moderate visual loss occurred in 9.1% of placebo-treated patients versus 5.5% of ruboxistaurin-treated patients (40% risk reduction, P = 0.034). Mean VA was better in the ruboxistaurin-treated patients after 12 months. Baseline-to-end point visual improvement of > or =15 letters was more frequent (4.9% vs. 2.4%) and > or =15-letter worsening was less frequent (6.7% vs. 9.9%) in ruboxistaurin-treated patients relative to placebo (P = 0.005). When clinically significant macular edema was >100 microm from the center of the macula at baseline, ruboxistaurin treatment was associated with less frequent progression of edema to within 100 microm (68% vs. 50%, P = 0.003). Initial laser treatment for macular edema was 26% less frequent in eyes of ruboxistaurin-treated patients (P = 0.008). CONCLUSION:
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Authors | PKC-DRS2 Group, Lloyd Paul Aiello, Matthew D Davis, Aniz Girach, Keri A Kles, Roy C Milton, Matthew J Sheetz, Louis Vignati, Xin Eric Zhi |
Journal | Ophthalmology
(Ophthalmology)
Vol. 113
Issue 12
Pg. 2221-30
(Dec 2006)
ISSN: 1549-4713 [Electronic] United States |
PMID | 16989901
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Enzyme Inhibitors
- Indoles
- Maleimides
- ruboxistaurin
- Protein Kinase C
- Protein Kinase C beta
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Topics |
- Administration, Oral
- Adult
- Aged
- Aged, 80 and over
- Diabetic Retinopathy
(drug therapy)
- Disease Progression
- Double-Blind Method
- Enzyme Inhibitors
(adverse effects, therapeutic use)
- Female
- Humans
- Indoles
(adverse effects, therapeutic use)
- Macular Edema
(drug therapy, physiopathology)
- Male
- Maleimides
(adverse effects, therapeutic use)
- Middle Aged
- Protein Kinase C
(antagonists & inhibitors)
- Protein Kinase C beta
- Vision Disorders
(prevention & control)
- Visual Acuity
(drug effects)
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