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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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) - 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.
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 - 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.
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 - 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.
Timepoint [1] 0 0
Baseline, 36 Months
Secondary outcome [2] 0 0
First Occurrence of Focal/Grid Photocoagulation - The first occurrence of focal/grid photocoagulation regardless of diabetic macular edema (DME) distance from the center of the macula.
Timepoint [2] 0 0
Baseline through 36 Months
Secondary outcome [3] 0 0
Change From Baseline in Contrast Sensitivity by Pelli-Robson - 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.
Timepoint [3] 0 0
Baseline, 36 Months
Secondary outcome [4] 0 0
Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography - 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.
Timepoint [4] 0 0
Baseline through 36 Months
Secondary outcome [5] 0 0
Change From Baseline in Estimated Glomerular Filtration Rate - 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.
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 - 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.
Timepoint [7] 0 0
36 Months
Secondary outcome [8] 0 0
Number of Participants With Adverse Events - Summaries of serious adverse events (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New Mexico
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
North Dakota
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oklahoma
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Dakota
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
Brazil
State/province [24] 0 0
Curitiba
Country [25] 0 0
Brazil
State/province [25] 0 0
Goiania
Country [26] 0 0
Brazil
State/province [26] 0 0
Sao Paulo
Country [27] 0 0
Canada
State/province [27] 0 0
British Columbia
Country [28] 0 0
Canada
State/province [28] 0 0
Nova Scotia
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Denmark
State/province [31] 0 0
Aarhus
Country [32] 0 0
Denmark
State/province [32] 0 0
Glostrup
Country [33] 0 0
France
State/province [33] 0 0
Bordeaux
Country [34] 0 0
France
State/province [34] 0 0
Nantes
Country [35] 0 0
France
State/province [35] 0 0
Paris
Country [36] 0 0
Germany
State/province [36] 0 0
Leipzig
Country [37] 0 0
Germany
State/province [37] 0 0
Munster
Country [38] 0 0
Germany
State/province [38] 0 0
Sulzbach
Country [39] 0 0
Germany
State/province [39] 0 0
Ulm
Country [40] 0 0
India
State/province [40] 0 0
Chennai
Country [41] 0 0
India
State/province [41] 0 0
Hyderabaad
Country [42] 0 0
India
State/province [42] 0 0
New Delhi
Country [43] 0 0
Italy
State/province [43] 0 0
Milano
Country [44] 0 0
Italy
State/province [44] 0 0
Udine
Country [45] 0 0
Mexico
State/province [45] 0 0
Mexico City
Country [46] 0 0
Netherlands
State/province [46] 0 0
Amsterdam
Country [47] 0 0
Netherlands
State/province [47] 0 0
Rotterdam
Country [48] 0 0
Poland
State/province [48] 0 0
Bydgoszcz
Country [49] 0 0
Poland
State/province [49] 0 0
Katowice
Country [50] 0 0
Poland
State/province [50] 0 0
Lublin
Country [51] 0 0
Poland
State/province [51] 0 0
Poznan
Country [52] 0 0
Portugal
State/province [52] 0 0
Coimbra
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Moscow
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Saint Petersburg
Country [55] 0 0
Spain
State/province [55] 0 0
Alicante
Country [56] 0 0
Spain
State/province [56] 0 0
Barcelona
Country [57] 0 0
Spain
State/province [57] 0 0
Madrid
Country [58] 0 0
Spain
State/province [58] 0 0
Valladolid
Country [59] 0 0
Taiwan
State/province [59] 0 0
Tao-Yuan
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Merseyside
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Scotland
Country [62] 0 0
United Kingdom
State/province [62] 0 0
West Midlands
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Bristol
Country [64] 0 0
United Kingdom
State/province [64] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Chromaderm, Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00090519
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

Summary results
Other publications