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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
History of Changes

August 26, 2004
February 25, 2011
February 2004
April 2010   (final data collection date for primary outcome measure)
Mean duration of definite center of macula-involved diabetic macular edema [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00090519 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Reduction in the Occurrence of Center-Involved Diabetic Macular Edema
Reduction in the Occurrence of Center-Involved Diabetic Macular Edema

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetic Retinopathy
  • Drug: ruboxistaurin
    32 mg QD oral for up to 36 months
    Other Names:
    • LY333531
    • Arxxant
  • Drug: placebo
    QD oral for up to 36 months
  • Experimental: 1
    Intervention: Drug: ruboxistaurin
  • Placebo Comparator: 2
    Intervention: Drug: placebo
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 β 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
737
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Brazil,   Canada,   Denmark,   France,   Germany,   India,   Italy,   Mexico,   Netherlands,   Poland,   Portugal,   Russian Federation,   Spain,   Taiwan,   United Kingdom
 
NCT00090519
8211, B7A-MC-MBDL
No
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP