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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00090519 |
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.
Condition | Intervention | Phase |
---|---|---|
Diabetic Retinopathy |
Drug: ruboxistaurin Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Reduction in the Occurrence of Center-Involved Diabetic Macular Edema |
Enrollment: | 731 |
Study Start Date: | February 2004 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: ruboxistaurin
32 mg QD oral for up to 36 months
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2: Placebo Comparator |
Drug: placebo
QD oral for up to 36 months
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
Study ID Numbers: | 8211, B7A-MC-MBDL |
Study First Received: | August 26, 2004 |
Last Updated: | September 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00090519 |
Health Authority: | United States: Food and Drug Administration |
Eye Diseases Vascular Diseases Diabetes Mellitus Edema Endocrine System Diseases Macular Degeneration Retinal Degeneration Diabetic Angiopathies |
Macular Edema Diabetic Retinopathy Ruboxistaurin Endocrinopathy Retinal Diseases Diabetes Complications Retinal degeneration |
Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Cardiovascular Diseases Pharmacologic Actions |