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Sponsored by: |
Eli Lilly and Company |
Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00133952 |
The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin for approximately 24 months will reduce the baseline to endpoint changes in macular thickness, as measured by optical coherence tomography (OCT), in patients with clinically significant macular edema.
Condition | Intervention | Phase |
Diabetic Macular Edema |
Drug: ruboxistaurin Drug: Placebo |
Phase III |
Genetics Home Reference related topics: | X-linked juvenile retinoschisis |
MedlinePlus related topics: | Edema |
Drug Information available for: | Ruboxistaurin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effect of Ruboxistaurin on Clinically Significant Macular Edema in Patients With Diabetes Mellitus, as Assessed by Optical Coherence Tomography |
Estimated Enrollment: | 300 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: ruboxistaurin
32 mg tablet daily for up to 48 months
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2: Placebo Comparator |
Drug: Placebo
One tablet daily for up to 48 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:
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 |
Show 36 Study Locations |
Eli Lilly and Company |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT- 5 hours, EST) | Eli Lilly and Company |
Lilly Clinical Trial Registry 
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Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
Study ID Numbers: | 5882, B7A-MC-MBCU |
First Received: | August 22, 2005 |
Last Updated: | September 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00133952 |
Health Authority: | United States: Food and Drug Administration |
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