MedTrace Logo

Reduction in the Occurrence of Center-Involved Diabetic Macular Edema

NCT00090519 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 731

Last updated 2016-10-06

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

ruboxistaurin

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

DRUG

placebo

QD oral for up to 36 months

Sponsors & Collaborators

  • Chromaderm, Inc.

    lead INDUSTRY

Principal Investigators

  • Karl Beutner · Chromaderm, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Denmark
  • France
  • Germany
  • India
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • Portugal
  • Russia
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00090519 on ClinicalTrials.gov