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Effect of Ruboxistaurin on Clinically Significant Macular Edema

NCT00133952 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 309

Last updated 2016-10-06

Study results available
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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

Interventions

DRUG

Ruboxistaurin

Administered orally

DRUG

Placebo

Administered orally

Sponsors & Collaborators

  • Chromaderm, Inc.

    lead INDUSTRY

Principal Investigators

  • Karl Beutner · Chromaderm, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States
  • Canada
  • Denmark
  • Germany
  • Lithuania
  • Mexico
  • Portugal
  • Romania
  • Spain
  • United Kingdom

Study Locations

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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 NCT00133952 on ClinicalTrials.gov