Reduction in the Occurrence of Center-Involved Diabetic Macular Edema - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00090519

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 III

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Diabetic Eye Problems Edema Retinal Disorders

Drug Information available for: Ruboxistaurin

U.S. FDA Resources

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

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:	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
1: Experimental	Drug: ruboxistaurin 32 mg QD oral for up to 36 months
2: Placebo Comparator	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

Show 84 Study Locations

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

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009