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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chromaderm, Inc.
• Treatments: Ruboxistaurin

Criteria

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