CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 731 enrolled
Drug / intervention
ruboxistaurin +1 moredrug
Likely dose
Ruboxistaurin 32 mg once daily orallyAI-extracted
Key inclusion· 5
  • ✓Type 1 or Type 2 diabetes
  • ✓Age 18 years or older
  • ✓Non-clinically significant diabetic macular edema
  • ✓Mild to moderate diabetic retinopathy in study eye
Key exclusion· 5
  • ✕Prior surgery or laser treatment in the study eye
  • ✕Glaucoma in the study eye
  • ✕Glycosylated hemoglobin (HbA1c) greater than 11%
  • ✕Systolic blood pressure greater than 170 mmHg

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00090519
NCT00090519Phase 3Completed
CompareCT.gov

Reduction in the Occurrence of Center-Involved Diabetic Macular Edema

Chromaderm, Inc.·interventional·Posted Aug 31, 2004·Updated Oct 6, 2016

In Brief

A Phase 3 clinical trial evaluating ruboxistaurin and placebo for Diabetic Retinopathy. Completed, enrolled 731 participants across 84 sites in 17 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Retinopathy
CountriesAustralia, Brazil, Canada, Denmark, France, Germany, India, Italy, Mexico, Netherlands, Poland, Portugal, Russia, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 31, 2004
Enrollment StartFeb 1, 2004
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 21.8 years ago

Interventions

ruboxistaurindrug

32 mg once daily (QD) oral for up to 36 months

placebodrug

QD oral for up to 36 months