NCT00133952

Effect of Ruboxistaurin on Clinically Significant Macular Edema

The Effect of Ruboxistaurin on Vision Loss in Patients With Diabetes Mellitus and Clinically Significant Macular Edema

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 309 (actual)
• Sponsor: Chromaderm, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Ruboxistaurin	Administered orally
DRUG	Placebo	Administered orally

Timeline

• Start date: 2005-08-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2005-08-24
• Last updated: 2016-10-06
• Results posted: 2016-01-28

Locations

41 sites across 10 countries: United States, Canada, Denmark, Germany, Lithuania, Mexico, Portugal, Romania, Spain, United Kingdom