Reduction in the Occurrence of Center-Involved Diabetic Macular Edema

This study has been completed.
Sponsor:
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
  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:


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:
  • LY333531
  • Arxxant
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090519

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Locations
United States, California
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Artesia, California, United States, 90701
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Palm Springs, California, United States, 92262
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Poway, California, United States, 92064
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Walnut Creek, California, United States, 94598
United States, Colorado
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Denver, Colorado, United States, 80262
United States, Connecticut
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New London, Connecticut, United States, 06320
United States, Florida
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United States, Georgia
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United States, Idaho
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United States, Illinois
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United States, Iowa
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United States, Maryland
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United States, Massachusetts
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Peabody, Massachusetts, United States, 01960
United States, Michigan
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Grand Rapids, Michigan, United States, 49525
United States, Missouri
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Independence, Missouri, United States, 64055
United States, New Jersey
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Houston, Texas, United States, 77030
United States, Utah
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Salt Lake City, Utah, United States, 84107
Australia, New South Wales
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Australia, South Australia
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Australia, Western Australia
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Glostrup, Denmark, 2600
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New Delhi, India, 110029
Italy
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Milano, Italy, 20132
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Mexico
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Netherlands
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Amsterdam, Netherlands, 1081 HV
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Poland
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Katowice, Poland, 40-044
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Poznan, Poland, 61-696
Portugal
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Coimbra, Portugal, 3000-548
Russian Federation
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Moscow, Russian Federation, 117036
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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
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Liverpool, Merseyside, United Kingdom, L7 8XP
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Aberdeen, Scotland, United Kingdom, AB25 2ZN
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Birmingham, West Midlands, United Kingdom, B9 5SS
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Bristol, United Kingdom, BS1 2LX
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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
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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:
Macular Edema
Diabetic Retinopathy
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Ruboxistaurin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014