CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 203 enrolled
Drug / intervention
Ruboxistaurindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00266695
NCT00266695Phase 3Completed
CompareCT.gov

Open-Label Treatment for Patients Completing Study B7A-MC-MBCM

Chromaderm, Inc.·interventional·Posted Dec 19, 2005·Updated Oct 6, 2016

In Brief

A Phase 3 clinical trial evaluating Ruboxistaurin for Diabetic Retinopathy. Completed, enrolled 203 participants across 29 sites.

Detailed Summary

To provide ruboxistaurin treatment to patients who completed the B7A-MC-MBCM study (NCT00604383), and who are felt by the investigator to have the potential to benefit from the ruboxistaurin treatment. Patients must be off study drug for 6 to 18 months from completion of B7A-MC-MBCM before beginning B7A-MC-MBDV. Additional data will be gathered to determine the long-term safety and effect of ruboxistaurin on vision.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Retinopathy
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 19, 2005
Enrollment StartJan 1, 2006
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 20.5 years ago

Interventions

Ruboxistaurindrug

32-milligram (mg) tablet, orally, once daily (QD) for up to 2 years.