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Clinical Trial: Treatment for Completers of the Study B7A-MC-MBCM
This study is not yet open for patient recruitment.
Verified by Eli Lilly and Company December 2005
|
Purpose
To provide ruboxistaurin treatment to patients who completed the MBCM study, and who are felt by the investigator to have the potential to benefit from the ruboxistaurin treatment. Additional data will be gathered to determine the long-term safety and effect of ruboxistaurin on vision.
| Condition | Intervention | Phase |
|---|---|---|
| Diabetic Retinopathy | Drug: ruboxistaurin | Phase III |
MedlinePlus related topics: Diabetic Eye Problems
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Open-Label Treatment for Patients Completing Study B7A-MC-MBCM
Further study details as provided by Eli Lilly and Company:
Primary Outcomes: To evaluate the effect of additional ruboxistaurin treatment on vision loss in patients with moderately severe to very severe nonproliferative diabetic retinopathy and any severity of DME.
Secondary Outcomes: To evaluate the effect of withdrawing ruboxistaurin on vision loss and to determine the long-term effect of ruboxistaurin treatment on vision loss.
Expected Total Enrollment: 400
Secondary Outcomes: To evaluate the effect of withdrawing ruboxistaurin on vision loss and to determine the long-term effect of ruboxistaurin treatment on vision loss.
Expected Total Enrollment: 400
Study start: December 2005; Expected completion: October 2006
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Patients that completed visit 15 of the study B7A-MC-MBCM, and the investigator believes he/she would benefit from ruboxistaurin treatment.
Exclusion Criteria:
- Patients that discontinued from the study B7A-MC-MBCM and/or the investigator does not believe he/she would benefit from ruboxistaurin treatment.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00266695
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
Indiana
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Indianapolis, Indiana, 46280, United States
Eli Lilly
Study chairs or principal investigators
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), Study Director, Eli Lilly and Company
More Information
Study ID Numbers: 10699
Last Updated: December 16, 2005
Record first received: December 15, 2005
ClinicalTrials.gov Identifier: NCT00266695
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: December 16, 2005
Record first received: December 15, 2005
ClinicalTrials.gov Identifier: NCT00266695
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
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