Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
Reduction in the Occurrence of Center-Involved Diabetic Macular Edema
Query!
Secondary ID [1]
0
0
B7A-MC-MBDL
Query!
Secondary ID [2]
0
0
8211
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Diabetic Retinopathy
0
0
Query!
Condition category
Condition code
Eye
0
0
0
0
Query!
Diseases / disorders of the eye
Query!
Metabolic and Endocrine
0
0
0
0
Query!
Diabetes
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
6 Months through 36 Months
Query!
Primary outcome [2]
0
0
Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline, 36 Months
Query!
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
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline, 36 Months
Query!
Secondary outcome [2]
0
0
First Occurrence of Focal/Grid Photocoagulation
Query!
Assessment method [2]
0
0
The first occurrence of focal/grid photocoagulation regardless of diabetic macular edema (DME) distance from the center of the macula.
Query!
Timepoint [2]
0
0
Baseline through 36 Months
Query!
Secondary outcome [3]
0
0
Change From Baseline in Contrast Sensitivity by Pelli-Robson
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline, 36 Months
Query!
Secondary outcome [4]
0
0
Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline through 36 Months
Query!
Secondary outcome [5]
0
0
Change From Baseline in Estimated Glomerular Filtration Rate
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline, 36 Months
Query!
Secondary outcome [6]
0
0
Change From Baseline at Endpoint in Albumin/Creatinine Ratio
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
36 Months
Query!
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
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
36 Months
Query!
Secondary outcome [8]
0
0
Number of Participants With Adverse Events
Query!
Assessment method [8]
0
0
Summaries of serious adverse events (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.
Query!
Timepoint [8]
0
0
Baseline through 36 Months
Query!
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)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/02/2004
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/04/2010
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
731
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Query!
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
Query!
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
Query!
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
Query!
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
Query!
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
Query!
Recruitment postcode(s) [1]
0
0
2150 - Parramatta
Query!
Recruitment postcode(s) [2]
0
0
2000 - Sydney
Query!
Recruitment postcode(s) [3]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [4]
0
0
5011 - Woodville
Query!
Recruitment postcode(s) [5]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Idaho
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Iowa
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Maryland
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Massachusetts
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Missouri
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New Jersey
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New Mexico
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New York
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
North Carolina
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
North Dakota
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Ohio
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Oklahoma
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Pennsylvania
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
South Dakota
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Texas
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Utah
Query!
Country [24]
0
0
Brazil
Query!
State/province [24]
0
0
Curitiba
Query!
Country [25]
0
0
Brazil
Query!
State/province [25]
0
0
Goiania
Query!
Country [26]
0
0
Brazil
Query!
State/province [26]
0
0
Sao Paulo
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
British Columbia
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
Nova Scotia
Query!
Country [29]
0
0
Canada
Query!
State/province [29]
0
0
Ontario
Query!
Country [30]
0
0
Canada
Query!
State/province [30]
0
0
Quebec
Query!
Country [31]
0
0
Denmark
Query!
State/province [31]
0
0
Aarhus
Query!
Country [32]
0
0
Denmark
Query!
State/province [32]
0
0
Glostrup
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Bordeaux
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Nantes
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Paris
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Leipzig
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Munster
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Sulzbach
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Ulm
Query!
Country [40]
0
0
India
Query!
State/province [40]
0
0
Chennai
Query!
Country [41]
0
0
India
Query!
State/province [41]
0
0
Hyderabaad
Query!
Country [42]
0
0
India
Query!
State/province [42]
0
0
New Delhi
Query!
Country [43]
0
0
Italy
Query!
State/province [43]
0
0
Milano
Query!
Country [44]
0
0
Italy
Query!
State/province [44]
0
0
Udine
Query!
Country [45]
0
0
Mexico
Query!
State/province [45]
0
0
Mexico City
Query!
Country [46]
0
0
Netherlands
Query!
State/province [46]
0
0
Amsterdam
Query!
Country [47]
0
0
Netherlands
Query!
State/province [47]
0
0
Rotterdam
Query!
Country [48]
0
0
Poland
Query!
State/province [48]
0
0
Bydgoszcz
Query!
Country [49]
0
0
Poland
Query!
State/province [49]
0
0
Katowice
Query!
Country [50]
0
0
Poland
Query!
State/province [50]
0
0
Lublin
Query!
Country [51]
0
0
Poland
Query!
State/province [51]
0
0
Poznan
Query!
Country [52]
0
0
Portugal
Query!
State/province [52]
0
0
Coimbra
Query!
Country [53]
0
0
Russian Federation
Query!
State/province [53]
0
0
Moscow
Query!
Country [54]
0
0
Russian Federation
Query!
State/province [54]
0
0
Saint Petersburg
Query!
Country [55]
0
0
Spain
Query!
State/province [55]
0
0
Alicante
Query!
Country [56]
0
0
Spain
Query!
State/province [56]
0
0
Barcelona
Query!
Country [57]
0
0
Spain
Query!
State/province [57]
0
0
Madrid
Query!
Country [58]
0
0
Spain
Query!
State/province [58]
0
0
Valladolid
Query!
Country [59]
0
0
Taiwan
Query!
State/province [59]
0
0
Tao-Yuan
Query!
Country [60]
0
0
United Kingdom
Query!
State/province [60]
0
0
Merseyside
Query!
Country [61]
0
0
United Kingdom
Query!
State/province [61]
0
0
Scotland
Query!
Country [62]
0
0
United Kingdom
Query!
State/province [62]
0
0
West Midlands
Query!
Country [63]
0
0
United Kingdom
Query!
State/province [63]
0
0
Bristol
Query!
Country [64]
0
0
United Kingdom
Query!
State/province [64]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Chromaderm, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00090519
Query!
Trial related presentations / publications
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 beta 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Karl Beutner
Query!
Address
0
0
Chromaderm, Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
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
Download to PDF