Ruboxistaurin (RBX) May Reduce Risk of Vision Loss in Diabetics

A multicenter international study chaired by a Joslin Diabetes Center investigator and reported in the July issue of the American Diabetes Association’s journal Diabetes brings hopeful news to the 18 million people in the United States — and millions more worldwide — with type 1 or type 2 diabetes. Initial results of the Phase III clinical trial demonstrated that 32 milligrams per day of ruboxistaurin (RBX) was well tolerated and may reduce the risk of moderate vision loss, especially in patients with diabetic macular edema.

In the double-masked, randomized multiple-dose study, 252 patients with type 1 or type 2 diabetes received either RBX or a placebo over a period of 3-4 years. The study measured the effect of three orally administered doses of RBX (8, 16, or 32 mg/day) on progression of diabetic retinopathy, moderate visual loss and sustained moderate visual loss. The study was conducted at Joslin Diabetes Center, medical centers across the United States as well as in Canada, Denmark, the Netherlands and United Kingdom.

“Our results demonstrate that although RBX did not prevent progression to proliferative diabetic retinopathy, it may reduce the risk of moderate vision loss caused by macular edema,” said study chairman Lloyd Paul Aiello, M.D., Ph.D., Head of Joslin’s Section on Eye Research, Director of Joslin’s Beetham Eye Institute and Associate Professor of Ophthalmology at Harvard Medical School. “If these findings hold true in a currently ongoing larger clinical trial, then RBX may eventually offer a new treatment option for patients with diabetes, especially in light of the lack of serious side effects reported to date.”

Link