Reduction in the Occurrence of Center-Involved Diabetic Macular Edema
NCT ID: NCT00090519
Last Updated: 2016-10-06
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
731 participants
Study Classification
INTERVENTIONAL
Study Start Date
2004-02-29
Study Completion Date
2010-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Diabetic Retinopathy
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Ruboxistaurin
32 milligrams (mg) once daily (QD) oral for up to 36 months
Group Type
EXPERIMENTAL
ruboxistaurin
Intervention Type
DRUG
32 mg once daily (QD) oral for up to 36 months
Placebo
QD oral for up to 36 months
Group Type
PLACEBO_COMPARATOR
placebo
Intervention Type
DRUG
QD oral for up to 36 months
Interventions
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ruboxistaurin
32 mg once daily (QD) oral for up to 36 months
Intervention Type
DRUG
placebo
QD oral for up to 36 months
Intervention Type
DRUG
Other Intervention Names
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LY333531
Arxxant
Eligibility Criteria
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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)
* 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
* Glycosylated hemoglobin (HbA1c) greater than 11%, or systolic blood pressure greater than 170 millimeters of mercury (mmHg)
* Liver disease, dialysis or renal transplant
* Glaucoma in the study eye
* Glycosylated hemoglobin (HbA1c) greater than 11%, or systolic blood pressure greater than 170 millimeters of mercury (mmHg)
* Liver disease, dialysis or renal transplant
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Chromaderm, Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Karl Beutner
Role: STUDY_DIRECTOR
Chromaderm, Inc.
Locations
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Artesia, California, United States
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Poway, California, United States
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Denver, Colorado, United States
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New London, Connecticut, United States
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Jacksonville, Florida, United States
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Augusta, Georgia, United States
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Hershey, Pennsylvania, United States
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Arlington, Texas, United States
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Curitiba, , Brazil
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Goiânia, , Brazil
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São Paulo, , Brazil
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Vancouver, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Aarhus, , Denmark
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Glostrup Municipality, , Denmark
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Bordeaux, , France
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Nantes, , France
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Leipzig, , Germany
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Münster, , Germany
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Sulzbach, , Germany
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Chennai, , India
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Hyderabaad, , India
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Milan, , Italy
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Udine, , Italy
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Amsterdam, , Netherlands
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Rotterdam, , Netherlands
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Bydgoszcz, , Poland
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Katowice, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Coimbra, , Portugal
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Moscow, , Russia
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Saint Petersburg, , Russia
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Alicante, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Valladolid, , Spain
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Taoyuan District, , Taiwan
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Liverpool, Merseyside, United Kingdom
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Aberdeen, Scotland, United Kingdom
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Birmingham, West Midlands, United Kingdom
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Bristol, , United Kingdom
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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
Site Status
Countries
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United States
Australia
Brazil
Canada
Denmark
France
Germany
India
Italy
Mexico
Netherlands
Poland
Portugal
Russia
Spain
Taiwan
United Kingdom
References
Explore related publications, articles, or registry entries linked to this study.
Sheetz MJ, Aiello LP, Davis MD, Danis R, Bek T, Cunha-Vaz J, Shahri N, Berg PH; MBDL and MBCU Study Groups. The effect of the oral PKC beta inhibitor ruboxistaurin on vision loss in two phase 3 studies. Invest Ophthalmol Vis Sci. 2013 Mar 11;54(3):1750-7. doi: 10.1167/iovs.12-11055.
Reference Type
DERIVED
Other Identifiers
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B7A-MC-MBDL
Identifier Type: OTHER
Identifier Source: secondary_id
8211
Identifier Type: -
Identifier Source: org_study_id
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