At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 685 enrolled
Drug / intervention
ruboxistaurin +1 moredrug
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.
Phase 3, Multicenter,Parallel,Randomized Dbl-masked,Placebo-controlled Study of the Effects of 32 mg/dy Ruboxistaurin Vision Loss in Patients With Type 1 or Type 2 Diabetes Mellitus and an Early Treatment Diabetic Retinopathy Study Level Between 47A and 53E.
In Brief
A Phase 3 clinical trial evaluating ruboxistaurin and placebo for Diabetic Retinopathy. Completed, enrolled 685 participants across 1 site.
Detailed Summary
This study is to test whether or not 32 milligrams (mg) of ruboxistaurin a day over three years will reduce vision loss associated with diabetic retinopathy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Retinopathy
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2001
Primary CompletionJun 2005
First PostedJan 2008
TodayJul 2026
First PostedJan 30, 2008
Enrollment StartMar 1, 2001
Primary CompletionJun 1, 2005
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 18.4 years ago
Interventions
ruboxistaurindrug
32-mg tablet, orally, daily, up to 42 months
placebodrug
1 tablet, orally, daily, up to 42 months