Reduction in the Occurrence of Center-Involved Diabetic Macular Edema
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00090519
First received: August 26, 2004
Last updated: February 25, 2011
Last verified: June 2010
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Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Reduction in the Occurrence of Center-Involved Diabetic Macular Edema |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Mean duration of definite center of macula-involved diabetic macular edema [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Visual acuity by ETDRS visual acuity chart [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
- First occurrence of focal/grid photocoagulation [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
- Visual Function, contrast sensitivity by Pelli-Robson [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
- Progression of nonproliferative diabetic retinopathy by seven-field stereo fundus photography [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
- Development or worsening of nephropathy by glomerular filtration rate [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
- Development or worsening of nephropathy by albumin/creatinine ratio [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Visual function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Adverse events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 737 |
| Study Start Date: | February 2004 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: ruboxistaurin
32 mg QD oral for up to 36 months
Other Names:
|
| Placebo Comparator: 2 |
Drug: placebo
QD oral for up to 36 months
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 1 or Type 2 diabetes
- 18 years or older
- Non-clinically significant diabetic macular edema
- Mild to moderate diabetic retinopathy in the study eye, vitreous hemorrhage in the study eye
- Relatively good vision (20/30 or better)
Exclusion Criteria:
- Surgery or laser treatment in the study eye
- Glaucoma in the study eye
- HA_I_C greater than 11%, or systolic blood pressure greater than 170 mm Hg
- Liver disease, dialysis or renal transplant
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00090519
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| Portugal | |
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| Saint Petersburg, Russian Federation, 195176 | |
| Spain | |
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| Alicante, Spain, 03015 | |
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| Barcelona, Spain, 08022 | |
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| Madrid, Spain, 28002 | |
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| Valladolid, Spain, 47005 | |
| Taiwan | |
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| Tao-Yuan, Taiwan, 333 | |
| United Kingdom | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Liverpool, Merseyside, United Kingdom, L7 8XP | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Birmingham, West Midlands, United Kingdom, B9 5SS | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Bristol, United Kingdom, BS1 2LX | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| London, United Kingdom, EC1V 2PD | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| 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 |
More Information
Additional Information:
No publications provided by Eli Lilly and Company
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00090519 History of Changes |
| Other Study ID Numbers: | 8211, B7A-MC-MBDL |
| Study First Received: | August 26, 2004 |
| Last Updated: | February 25, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetic Retinopathy Macular Edema Retinal Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications |
Diabetes Mellitus Endocrine System Diseases Macular Degeneration Retinal Degeneration Ruboxistaurin Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013