Reduction in the Occurrence of Center-Involved Diabetic Macular Edema

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

Inclusion Criteria:

• Type 1 or Type 2 diabetes

• 18 years or older

• Non-clinically significant diabetic macular edema

• Mild to moderate diabetic retinopathy in the study eye, vitreous hemorrhage in the study eye

• Relatively good vision (20/30 or better)

Exclusion Criteria:

• Surgery or laser treatment in the study eye

• Glaucoma in the study eye

• Glycosylated hemoglobin (HbA1c) greater than 11%, or systolic blood pressure greater than 170 millimeters of mercury (mmHg)

• Liver disease, dialysis or renal transplant