Reduction in the Occurrence of Center-Involved Diabetic Macular Edema

Phase 3 Completed 731 enrolled Chromaderm, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine if ruboxistaurin can help slow the worsening of an eye disease called macular edema in patients with diabetes.

Timeline

Start: 2004-02
Primary completion: 2010-04
Completion: 2010-04

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry Ruboxistaurin vs Placebo; p = 0.969; Mean Difference (Final Values) -0.01 (95% CI -0.714 to 0.686); ANOVA reads as missed primary endpoint NCT00090519 ↗

registry Ruboxistaurin vs Placebo; p = 0.081; Odds Ratio (OR) 0.47 (95% CI 0.20 to 1.12); Chi-squared reads as missed primary endpoint NCT00090519 ↗

release “reduced the risk of sustained moderate vision loss by 40 percent when compared to placebo in patients with moderate to severe non-proliferative diabetic retinopathy” reads as met primary endpoint lilly.com ↗

Publications

Sheetz MJ, Aiello LP, Davis MD, Danis R, Bek T, Cunha-Vaz J, Shahri N, Berg PH; MBDL and MBCU Study Groups. The effect of the oral PKC beta inhibitor ruboxistaurin on vision loss in two phase 3 studies. Invest Ophthalmol Vis Sci. 2013 Mar 11;54(3):1750-7. doi: 10.1167/iovs.12-11055.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ruboxistaurin	Small molecule	32 mg	Oral