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Effect of Ruboxistaurin on Clinically Significant Macular Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00133952
Recruitment Status : Completed
First Posted : August 24, 2005
Results First Posted : January 28, 2016
Last Update Posted : October 6, 2016
Sponsor:
Information provided by (Responsible Party):
Chromaderm, Inc.

Study Description
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Brief Summary:
The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin will reduce the occurrence of sustained moderate visual loss (SMVL) in patients with clinically significant macular edema. SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the patient's last 6 months of study participation. The SMVL data from this study will be combined with the SMVL data from Study B7A-MC-MBDL for the purpose of comparing ruboxistaurin to placebo.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Ruboxistaurin Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 309 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Ruboxistaurin on Vision Loss in Patients With Diabetes Mellitus and Clinically Significant Macular Edema
Study Start Date : August 2005
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ruboxistaurin
32 mg taken orally daily for up to 48 months
 Drug: Ruboxistaurin
Administered orally
Other Name: LY333531
Placebo Comparator: Placebo
Taken orally daily for up to 48 months
 Drug: Placebo
Administered orally


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Sustained Moderate Visual Loss (SMVL) Any Time Baseline Through Month 48 [ Time Frame: Baseline through 48 months ]
    SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the participant's last 6 months of study participation. ETDRS visual acuity uses an eye chart with 5 letters per line. The scores range from 0 (no letters read correctly) to 100 (all letters read correctly).


Secondary Outcome Measures :
  1. Change From Baseline to Month 24 in Mean Retinal Thickness Within 500 Microns of the Center of the Macula [ Time Frame: Baseline, 24 months ]
    Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.

  2. Number of Eyes With Significant Center-Involved Macular Edema at Any Time From Baseline Through Month 24 [ Time Frame: Baseline through 24 months ]
    Significant center-involved macular edema is defined as an absolute retinal thickness at the center of the macula >2 standard deviations above the mean baseline value (where the mean and standard deviation are calculated at baseline from the randomized population of participants with retinal thickness values of ≤ 300 microns in depth).

  3. Time to Focal Photocoagulation [ Time Frame: Baseline through 48 months ]
  4. Change From Baseline to Month 24 in Contrast Sensitivity [ Time Frame: Baseline, 24 months ]
    Values are presented as changes in the number of letters read correctly on the Pelli-Robson contrast sensitivity chart which consists of 16 triplets (48 letters total) with letters of the same size but decreasing contrast. Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.

  5. Change From Baseline to Month 24 in Retinal Thickness at the Center of the Macula [ Time Frame: Baseline, up to 24 months ]
  6. Number of Participants Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24 [ Time Frame: Baseline through 24 months ]
  7. Number of Participants Not Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24 [ Time Frame: Baseline through 24 months ]
  8. Number of Participants Requiring Repeat Focal Photocoagulation at Any Time From Baseline Though Month 24 [ Time Frame: Baseline through 24 months ]
    Repeat focal photocoagulation is defined as 2 or more focal photocoagulation treatments needed during the study.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 or 2 diabetes
  • 18 years or older
  • Hemoglobin A1c (HbA1c) less than or equal to 11%
  • Mild to very severe non-proliferative diabetic retinopathy in the study eye
  • Clinically significant macular edema in the study eye not within 100 microns of center of macula

Exclusion Criteria:

  • Previous surgery or laser treatment (or need for laser treatment within 3 months) in the study eye
  • Glaucoma in the study eye
  • Unstable cardiovascular disease
  • Major surgery within past 3 months
  • Significantly impaired kidney or liver function, or malignancy requiring chemotherapy or radiation therapy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00133952


Locations
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United States, Arizona
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Phoenix, Arizona, United States, 85020
United States, California
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Artesia, California, United States, 90701
United States, Delaware
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Newark, Delaware, United States, 19713
United States, Florida
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Jacksonville, Florida, United States, 32204
United States, Georgia
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Augusta, Georgia, United States, 30909
United States, Indiana
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Indianapolis, Indiana, United States, 46280
United States, Maryland
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Baltimore, Maryland, United States, 21287
United States, Massachusetts
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Boston, Massachusetts, United States, 02215
United States, Michigan
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Grand Rapids, Michigan, United States, 49525
United States, New Hampshire
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Portsmouth, New Hampshire, United States, 03801
United States, New York
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Slingerlands, New York, United States, 12159
United States, North Carolina
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Asheville, North Carolina, United States, 28803
United States, Ohio
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Lakewood, Ohio, United States, 44107
United States, Pennsylvania
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Kingston, Pennsylvania, United States, 18704
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Pittsburgh, Pennsylvania, United States, 15213
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West Mifflin, Pennsylvania, United States, 15122
United States, Texas
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Dallas, Texas, United States, 75231
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Houston, Texas, United States, 77030
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San Antonio, Texas, United States, 78229
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
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London, Ontario, Canada, N6A 4G5
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Mississauga, Ontario, Canada, L4W 1W0
Denmark
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Aarhus, Denmark, 8000
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Glostrup, Denmark, 2600
Germany
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Bonn, Germany, 53127
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Leipzig, Germany, 04103
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Münster, Germany, 48145
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Ulm, Germany, 89075
Lithuania
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Kaunas, Lithuania, LT-50009
Mexico
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Mexico City, Mexico, 6700
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Monterrey, Mexico, 64710
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San Luis Potosi, Mexico, 78395
Portugal
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Coimbra, Portugal, 3000-548
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Lisbon, Portugal, 1150-199
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Porto, Portugal, 4202-451
Romania
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Bucharest, Romania, 050098
Spain
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Alicante, Spain, 03016
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Barcelona, Spain, 08022
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Valladolid, Spain, 47071
United Kingdom
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London, Greater London, United Kingdom, SE5 9RS
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London, United Kingdom, EC1V 2PD
Sponsors and Collaborators
Chromaderm, Inc.
Investigators
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Study Director: Karl Beutner Chromaderm, Inc.
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chromaderm, Inc.
ClinicalTrials.gov Identifier: NCT00133952    
Other Study ID Numbers: 5882
B7A-MC-MBCU ( Other Identifier: Eli Lilly and Company )
First Posted: August 24, 2005    Key Record Dates
Results First Posted: January 28, 2016
Last Update Posted: October 6, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
 Eye Diseases
Ruboxistaurin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action