Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study

Phase 3 Completed 685 enrolled Chromaderm, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

This study is to test whether or not 32 milligrams (mg) of ruboxistaurin a day over three years will reduce vision loss associated with diabetic retinopathy.

Timeline

Start: 2001-03
Primary completion: 2005-06
Completion: 2005-06

Outcome

Met primary endpoint

registry NUMBER Ruboxistaurin: 5.5 percentage of participants NUMBER Placebo: 9.1 percentage of participants analysis (superiority or other test); Ruboxistaurin vs Placebo; p = 0.034; Cochran-Mantel-Haenszel NCT00604383 ↗

Publications

Davis MD, Sheetz MJ, Aiello LP, Milton RC, Danis RP, Zhi X, Girach A, Jimenez MC, Vignati L; PKC-DRS2 Study Group. Effect of ruboxistaurin on the visual acuity decline associated with long-standing diabetic macular edema. Invest Ophthalmol Vis Sci. 2009 Jan;50(1):1-4. doi: 10.1167/iovs.08-2473. Epub 2008 Aug 15.

Drugs

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