Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Reduction in the Occurrence of Center-Involved Diabetic Macular Edema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chromaderm, Inc.
ClinicalTrials.gov Identifier:
NCT00090519
First received: August 26, 2004
Last updated: July 25, 2016
Last verified: July 2016
  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 Chromaderm, Inc.:

Primary Outcome Measures:
  • Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME) [ Time Frame: 6 Months through 36 Months ] [ Designated as safety issue: No ]
    Duration of center of macula involvement when primary study outcome (DME involvement in center of macula determined by central grading of stereoscopic fundus photographs) was identified at a visit, participant was considered to have had definite center involvement for a specified length of time between the adjacent visits. Total duration of center involvement was calculated. Mean duration was total duration of center involvement divided by total number of participants. Participant durations were summarized, total number of months of center involvement in both treatment groups were displayed.

  • Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye [ Time Frame: Baseline, 36 Months ] [ Designated as safety issue: No ]
    The occurrence of SMVL was defined as ≥15 letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) in any DR study eye relative to baseline that is sustained for the last 6 months of participation. ETDRS VA: participant starts at the top of the chart containing 5 letters per row and reads down the chart until reaching a row where a minimum of 3 letters on a line cannot be read. Participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity.


Secondary Outcome Measures:
  • Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months [ Time Frame: Baseline, 36 Months ] [ Designated as safety issue: No ]
    ETDRS VA: participant starts at the top of the chart containing 5 letters per row and reads down the chart until reaching a row where a minimum of 3 letters on a line cannot be read. Participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity. Results are reported based on the number of diabetic retinopathy (DR) eyes.

  • First Occurrence of Focal/Grid Photocoagulation [ Time Frame: Baseline through 36 Months ] [ Designated as safety issue: No ]
    The first occurrence of focal/grid photocoagulation regardless of diabetic macular edema (DME) distance from the center of the macula.

  • Change From Baseline in Contrast Sensitivity by Pelli-Robson [ Time Frame: Baseline, 36 Months ] [ Designated as safety issue: No ]
    Pelli-Robson chart read from left to right + from top to bottom. Each line has 2 groups, each of 3 letters. Letters in each group have same contrast. Contrast in each successive group is less than the preceding group. Participant reads letters starting with highest contrast, continues until 2 or 3 letters in 1 group are incorrectly named. Scored on key showing all letters at full contrast, gives the log contrast sensitivity corresponding to each group. Score is determined by previous group (last group in which 2 or 3 letters were correctly named). Results reported based on number of DR eyes.

  • Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography [ Time Frame: Baseline through 36 Months ] [ Designated as safety issue: No ]
    Participants were classified as having experienced progression or no progression of DR by 36-month visit. Progression of DR=3 steps on ETDRS retinopathy severity person scale for participants with both eyes less than proliferative diabetic retinopathy (PDR) at baseline OR 2 steps on ETDRS retinopathy severity eye scale for participants with 1 eye less than PDR at baseline OR application of panretinal laser therapy. Participants were assigned at baseline to ETDRS retinopathy severity scale for persons or individual eyes; determination of no progression/progression was dependent on the scale.

  • Change From Baseline in Estimated Glomerular Filtration Rate [ Time Frame: Baseline, 36 Months ] [ Designated as safety issue: No ]
    The Modification of Diet in Renal Disease (MDRD) study formula used for the estimated glomerular filtration rate (eGFR) determination is: eGFR = 170 X (Serum creatinine concentration [mg/deciliter (dL)])-0.999 X (Age [years]) -0.176 X (0.762 if participant is female) X (1.180 if participant is black) X (Serum urea nitrogen concentration [mg/dL])-0.170 X (Serum albumin concentration [grams (g)/dL])+0.318.

  • Change From Baseline at Endpoint in Albumin/Creatinine Ratio [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
    25 vision-targeted questions representing 11 vision-related constructs and a 1-item general health rating question. Measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning and task-oriented domains related to daily visual functioning. Each item is converted to a 0 to 100 scale such that a higher score represents better functioning.

  • Number of Participants With Adverse Events [ Time Frame: Baseline through 36 Months ] [ Designated as safety issue: Yes ]
    Summaries of serious adverse events (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.


Enrollment: 731
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: Ruboxistaurin
32 milligrams (mg) once daily (QD) oral for up to 36 months
Drug: ruboxistaurin
32 mg once daily (QD) oral for up to 36 months
Other Names:
  • LY333531
  • Arxxant
Placebo Comparator: Placebo
QD oral for up to 36 months
Drug: placebo
QD oral for up to 36 months

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  • Glycosylated hemoglobin (HbA1c) greater than 11%, or systolic blood pressure greater than 170 millimeters of mercury (mmHg)
  • 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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Jacksonville, Florida, United States, 32204
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Sunrise, Florida, United States, 33351
United States, Georgia
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Augusta, Georgia, United States, 30909
United States, Idaho
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Idaho Falls, Idaho, United States, 83404
United States, Illinois
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Wheaton, Illinois, United States, 60187
United States, Iowa
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Iowa City, Iowa, United States, 52242
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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Columbia, Missouri, United States, 65212
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Independence, Missouri, United States, 64055
United States, New Jersey
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New Brunswick, New Jersey, United States, 08901
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Teaneck, New Jersey, United States, 07666
United States, New Mexico
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Albuquerque, New Mexico, United States, 87102
United States, New York
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Rockville Center, New York, United States, 11570
United States, North Carolina
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Charlotte, North Carolina, United States, 28210
United States, North Dakota
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Fargo, North Dakota, United States, 58104
United States, Ohio
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Beachwood, Ohio, United States, 44122
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United States, Oklahoma
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United States, Pennsylvania
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United States, South Dakota
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Rapid City, South Dakota, United States, 57701
United States, Texas
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Arlington, Texas, United States, 76012
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Houston, Texas, United States, 77030
United States, Utah
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Ogden, Utah, United States, 84403
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Salt Lake City, Utah, United States, 84107
Australia, New South Wales
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Parramatta, New South Wales, Australia, 2150
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Sydney, New South Wales, Australia, 2000
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Westmead, New South Wales, Australia, 2145
Australia, South Australia
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Woodville, South Australia, Australia, 5011
Australia, Western Australia
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Nedlands, Western Australia, Australia, 6009
Brazil
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Curitiba, Brazil, 80420-170
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Goiania, Brazil, 74210-010
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Sao Paulo, Brazil, 05403-010
Canada, British Columbia
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Canada, Nova Scotia
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Canada, Ontario
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Canada, Quebec
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Denmark
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Aarhus, Denmark, 8000
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Glostrup, Denmark, 2600
France
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Bordeaux, France, 33076
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Nantes, France, 44093
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Paris, France, 75010
Germany
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Leipzig, Germany, 04103
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Munster, Germany, 48145
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Sulzbach, Germany, 66280
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Ulm, Germany, D-89075
India
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Chennai, India, 600006
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Hyderabaad, India, 500034
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New Delhi, India, 110029
Italy
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Milano, Italy, 20132
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Udine, Italy, 33100
Mexico
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Mexico City, Mexico, 04030
Netherlands
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Amsterdam, Netherlands, 1081 HV
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Rotterdam, Netherlands, 3011 BH
Poland
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Bydgoszcz, Poland, 85-822
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Katowice, Poland, 40-044
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Lublin, Poland, 20-081
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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
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.
Bristol, United Kingdom, BS1 2LX
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, EC1V 2PD
Sponsors and Collaborators
Chromaderm, Inc.
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chromaderm, Inc.
ClinicalTrials.gov Identifier: NCT00090519     History of Changes
Other Study ID Numbers: 8211  B7A-MC-MBDL 
Study First Received: August 26, 2004
Results First Received: December 22, 2015
Last Updated: July 25, 2016
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

ClinicalTrials.gov processed this record on September 30, 2016