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

Phase 3, Multicenter,Parallel,Randomized Dbl-masked,Placebo-controlled Study of the Effects of 32 mg/dy Ruboxistaurin Vision Loss in Patients With Type 1 or Type 2 Diabetes Mellitus and an Early Treatment Diabetic Retinopathy Study Level Between 47A and 53E.

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.

Inclusion Criteria:

• Type 1 or Type 2 diabetes mellitus
• 18 years or older
• Meet specific requirements for diabetic retinopathy
• Free of severe or chronically disabling conditions, except diabetes, diabetic retinopathy and diabetic macular edema
• Hemoglobin A1c (HbA1C) ≤13.0%

Exclusion Criteria:

• History of panretinal photocoagulation for diabetic retinopathy, conditions that might affect the progression of diabetic retinopathy, or unstable angina
• Investigators, site personnel directly affiliated with the study and their families
• Presence of eye disorders that may affect the progression of diabetic retinopathy or cause vision loss
• Presence of medical disorder, cancer, or elevated laboratory measurements that could represent a safety risk during the study
• Women who are pregnant, breastfeeding, intend to become pregnant, or who are sexually active without using an acceptable method of birth control