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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00090519
Registration number
NCT00090519
Ethics application status
Date submitted
26/08/2004
Date registered
31/08/2004
Date last updated
6/10/2016
Titles & IDs
Public title
Reduction in the Occurrence of Center-Involved Diabetic Macular Edema
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Scientific title
Reduction in the Occurrence of Center-Involved Diabetic Macular Edema
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Secondary ID [1]
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B7A-MC-MBDL
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Secondary ID [2]
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8211
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetic Retinopathy
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ruboxistaurin
Treatment: Drugs - placebo
Experimental: Ruboxistaurin - 32 milligrams (mg) once daily (QD) oral for up to 36 months
Placebo Comparator: Placebo - QD oral for up to 36 months
Treatment: Drugs: ruboxistaurin
32 mg once daily (QD) oral for up to 36 months
Treatment: Drugs: placebo
QD oral for up to 36 months
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME)
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Assessment method [1]
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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.
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Timepoint [1]
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6 Months through 36 Months
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Primary outcome [2]
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Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline, 36 Months
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Secondary outcome [1]
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Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, 36 Months
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Secondary outcome [2]
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First Occurrence of Focal/Grid Photocoagulation
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Assessment method [2]
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The first occurrence of focal/grid photocoagulation regardless of diabetic macular edema (DME) distance from the center of the macula.
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Timepoint [2]
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Baseline through 36 Months
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Secondary outcome [3]
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Change From Baseline in Contrast Sensitivity by Pelli-Robson
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, 36 Months
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Secondary outcome [4]
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Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline through 36 Months
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Secondary outcome [5]
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Change From Baseline in Estimated Glomerular Filtration Rate
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline, 36 Months
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Secondary outcome [6]
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Change From Baseline at Endpoint in Albumin/Creatinine Ratio
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Assessment method [6]
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Timepoint [6]
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36 Months
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Secondary outcome [7]
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Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months
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Assessment method [7]
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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.
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Timepoint [7]
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36 Months
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Secondary outcome [8]
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Number of Participants With Adverse Events
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Assessment method [8]
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Summaries of serious adverse events (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.
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Timepoint [8]
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Baseline through 36 Months
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Eligibility
Key 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)
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2010
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Sample size
Target
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Accrual to date
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Final
731
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Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
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Recruitment hospital [1]
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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. - Parramatta
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Recruitment hospital [2]
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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. - Sydney
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Recruitment hospital [3]
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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. - Westmead
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Recruitment hospital [4]
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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. - Woodville
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Recruitment hospital [5]
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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. - Nedlands
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Recruitment postcode(s) [1]
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2150 - Parramatta
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Recruitment postcode(s) [2]
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2000 - Sydney
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment postcode(s) [4]
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5011 - Woodville
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment outside Australia
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California
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Colorado
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Chromaderm, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/ct2/show/NCT00090519
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Karl Beutner
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Address
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Chromaderm, Inc.
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00090519
Download to PDF