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Protein kinase inhibitor reduced vision loss in diabetic retinopathy, study says
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SAO PAULO, Brazil — In patients with moderate to severe nonproliferative diabetic retinopathy, orally administered ruboxistaurin reduced the occurrence of moderate vision loss by 40%, said one researcher here.
Aniz Girach, MD, and colleagues at the Lilly Research Lab in the United Kingdom randomly assigned 685 patients in a study to receive either ruboxistaurin or placebo. Ruboxistaurin is a protein kinase C beta inhibitor that targets a “key underlying process that causes diabetic microvascular damage,” according to Lilly materials.
The primary endpoint of the study was a sustained moderate (three lines) visual acuity loss for the last 6 months of the 3-year study. Patients with “moderately severe to very severe” nonproliferative diabetic retinopathy, a best-corrected visual acuity score of 45 letters on the ETDRS chart, and no prior photocoagulation in the study eye were included in the study, Dr. Girach said.
Of 340 patients taking placebo, 9.1% experienced a sustained moderate vision loss. Of 345 patients taking ruboxistaurin, 5.5% had a sustained moderate vision loss, Dr. Girach said.
The researchers said 28 patients taking ruboxistaurin gained 15 letters compared with 14 patients taking placebo (P = 0.027); 38 patients taking ruboxistaurin lost 15 letters compared with 57 taking placebo (P = 0.44), Dr. Girach said. No major differences were seen between the two groups in discontinuation or demographic information.
Other physicians involved in the study include Alexander J. Brucker, MD; Lloyd P. Aiello, MD; Louis Vignati, MD; Matthew Sheetz, MD; Matthew D. Davis, MD; and Roy C. Milton, MD, Dr. Girach said at the World Ophthalmology Congress.
Pending regulatory approvals, Eli Lilly & Co. plans to market ruboxistaurin under the brand name Arxxant.