Effect of Ruboxistaurin on Clinically Significant Macular Edema

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

Inclusion Criteria:

• Type 1 or 2 diabetes

• 18 years or older

• Hemoglobin A1c (HbA1c) less than or equal to 11%

• Mild to very severe non-proliferative diabetic retinopathy in the study eye

• Clinically significant macular edema in the study eye not within 100 microns of center of macula

Exclusion Criteria:

• Previous surgery or laser treatment (or need for laser treatment within 3 months) in the study eye

• Glaucoma in the study eye

• Unstable cardiovascular disease

• Major surgery within past 3 months

• Significantly impaired kidney or liver function, or malignancy requiring chemotherapy or radiation therapy.