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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Reduction in the Occurrence of Center-Involved Diabetic Macular Edema
Secondary ID [1] 0 0
B7A-MC-MBDL
Secondary ID [2] 0 0
8211
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Retinopathy 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME)
Timepoint [1] 0 0
6 Months through 36 Months
Primary outcome [2] 0 0
Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye
Timepoint [2] 0 0
Baseline, 36 Months
Secondary outcome [1] 0 0
Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months
Timepoint [1] 0 0
Baseline, 36 Months
Secondary outcome [2] 0 0
First Occurrence of Focal/Grid Photocoagulation
Timepoint [2] 0 0
Baseline through 36 Months
Secondary outcome [3] 0 0
Change From Baseline in Contrast Sensitivity by Pelli-Robson
Timepoint [3] 0 0
Baseline, 36 Months
Secondary outcome [4] 0 0
Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography
Timepoint [4] 0 0
Baseline through 36 Months
Secondary outcome [5] 0 0
Change From Baseline in Estimated Glomerular Filtration Rate
Timepoint [5] 0 0
Baseline, 36 Months
Secondary outcome [6] 0 0
Change From Baseline at Endpoint in Albumin/Creatinine Ratio
Timepoint [6] 0 0
36 Months
Secondary outcome [7] 0 0
Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months
Timepoint [7] 0 0
36 Months
Secondary outcome [8] 0 0
Number of Participants With Adverse Events
Timepoint [8] 0 0
Baseline through 36 Months

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2010
Sample size
Target
Accrual to date
Final
731
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Recruitment hospital [1] 0 0
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
Recruitment hospital [2] 0 0
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
Recruitment hospital [3] 0 0
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
Recruitment hospital [4] 0 0
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
Recruitment hospital [5] 0 0
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
Recruitment postcode(s) [1] 0 0
2150 - Parramatta
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
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California
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Colorado
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Connecticut
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Chromaderm, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Karl Beutner
Address 0 0
Chromaderm, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00090519