Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00604383
First received: January 17, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
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Purpose
This study is to test whether or not 32mg of ruboxistaurin a day over three years will reduce vision loss associated with diabetic retinopathy.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Retinopathy |
Drug: ruboxistaurin mesylate Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase 3, Multicenter,Parallel,Randomized Dbl-Masked,Placebo-Controlled Study of the Effects of 32 mg/dy Ruboxistaurin Vision Loss in Patients With Type 1 or Type 2 Diabetes Mellitus and an Early Treatment Diabetic Retinopathy Study Level Between 47A and 53E. |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Occurrence of Sustained Moderate Visual Loss (SMVL) as defined as a visual acuity loss of >= 15 letters measured twice during a 6 month period. [ Time Frame: 3 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Secondary efficacy measures were evaluated using a gatekeeping strategy. Safety was also assessed. [ Time Frame: 3 year ] [ Designated as safety issue: No ]
| Enrollment: | 685 |
| Study Start Date: | March 2001 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Ruboxistaurin
|
Drug: ruboxistaurin mesylate
32mg tablet, oral, daily, 3 years
Other Name: LY333351
|
| Placebo Comparator: 2 |
Drug: placebo
1 tab, oral, daily, 3 years
|
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 mellitus
- 18 years or older
- Meet specific requirements for diabetic retinopathy
- Free of severe or chronically disabling conditions, except diabetes, diabetic retinopathy and diabetic macular edema
- HbA1C <= 13.0%
Exclusion Criteria:
- History of panretinal photocoagulation for diabetic retinopathy, conditions that might affect the progression of diabetic retinopathy, or unstable angina
- Investigators, site personnel directly affiliated with the study and their families
- Presence of eye disorders that may affect the progression of diabetic retinopathy or cause vision loss
- Presence of medical disorder, cancer, or elevated measurements that could pose a safety risk during the study
- Women who are pregnant, breastfeeding, intend to become pregnant, or who are sexually active without using an acceptable method of birth control
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604383
Locations
| United States, Indiana | |
| 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. | |
| Indianapolis, Indiana, United States | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 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: | NCT00604383 History of Changes |
| Other Study ID Numbers: | 4743, B7A-MC-MBCM |
| Study First Received: | January 17, 2008 |
| Last Updated: | January 17, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus, Type 2 Diabetic Retinopathy Retinal Diseases Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Eye Diseases |
Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Ruboxistaurin Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013