Effect of Ruboxistaurin on Clinically Significant Macular Edema

Summary

The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin will reduce the occurrence of sustained moderate visual loss (SMVL) in patients with clinically significant macular edema. SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the patient's last 6 months of study participation. The SMVL data from this study will be combined with the SMVL data from Study B7A-MC-MBDL for the purpose of comparing ruboxistaurin to placebo.

Timeline

Start

2005-08

Primary completion

2011-07

Completion

2011-07

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo vs Ruboxistaurin; p = 0.724; Odds Ratio (OR) 0.63 (95% CI 0.15 to 2.67); Fisher Exact NCT00133952 ↗

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

Indications