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: August 25, 2016
Last verified: August 2016
Results First Received: December 22, 2015  
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
Condition: Diabetic Retinopathy
Interventions: Drug: ruboxistaurin
Drug: placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ruboxistaurin 32 mg once daily (QD) oral for up to 36 months
Placebo QD oral for up to 36 months

Participant Flow:   Overall Study
    Ruboxistaurin   Placebo
STARTED   371   360 
COMPLETED   298   285 
NOT COMPLETED   73   75 
Adverse Event                5                4 
Death                9                9 
Lost to Follow-up                26                29 
Withdrawal by Subject                28                29 
Physician Decision                2                3 
Sponsor Decision                3                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ruboxistaurin 32 mg once daily (QD) oral for up to 36 months
Placebo QD oral for up to 36 months
Total Total of all reporting groups

Baseline Measures
   Ruboxistaurin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 371   360   731 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.20  (10.85)   55.15  (11.18)   55.17  (11.01) 
Gender 
[Units: Participants]
     
Female   138   137   275 
Male   233   223   456 
Region of Enrollment 
[Units: Participants]
     
United States   93   97   190 
Portugal   15   16   31 
Taiwan   3   1   4 
Spain   13   11   24 
Russian Federation   28   24   52 
United Kingdom   21   18   39 
Italy   8   6   14 
India   25   26   51 
France   11   10   21 
Mexico   22   22   44 
Canada   22   25   47 
Brazil   13   16   29 
Poland   20   16   36 
Australia   20   17   37 
Denmark   26   28   54 
Netherlands   9   8   17 
Germany   22   19   41 
Body Mass Index (BMI) [1] 
[Units: Kilograms/square meters (kg/m^2)]
Mean (Standard Deviation)
 29.90  (6.09)   29.82  (5.89)   29.86  (5.99) 
[1] Body mass index is an estimate of body fat based on body weight divided by height squared.
Blood Pressure 
[Units: Millimeters of mercury (mmHg)]
Mean (Standard Deviation)
     
Systolic Blood Pressure   132.90  (15.25)   133.50  (15.58)   133.20  (5.99) 
Diastolic Blood Pressure   77.68  (8.68)   77.77  (9.05)   77.73  (8.86) 
Glycosylated hemoglobin (HbA1c) 
[Units: Percent glycosylated hemoglobin]
Mean (Standard Deviation)
 8.14  (1.31)   8.25  (1.31)   8.19  (1.31) 
Diabetes Type [1] 
[Units: Participants]
     
Type 1   85   76   161 
Type 2   286   284   570 
[1] Type 1 diabetes results from autoimmune mediated destruction of the beta cells of the pancreas. Participants require insulin treatment to survive. Type 2 diabetes is characterized by resistance to the action of insulin leading to relative insulin deficiency.
Duration of diabetes 
[Units: Years]
Mean (Standard Deviation)
 15.82  (8.00)   15.57  (7.48)   15.70  (7.75) 
Insulin use 
[Units: Participants]
     
Yes   241   228   469 
No   130   132   262 
Number of diabetic retinopathy (DR) study eyes per participant 
[Units: Participants]
     
Two   351   336   687 
One   20   24   44 
Visual Acuity Score (Letters Correct) [1] 
[Units: Letters read correctly]
Mean (Standard Deviation)
 84.12  (7.93)   84.27  (7.70)   84.19  (7.81) 
[1] Visual acuity by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Each 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. Each participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity.
Diabetic Retinopathy (DR) Level [1] 
[Units: DR study eyes for each level]
     
<47   465   421   886 
47   250   272   522 
53   7   3   10 
[1] DR level is reported by number of DR study eyes for each level (722 DR study eyes in ruboxistaurin group and 696 DR study eyes in placebo group). EDTRS Final Retinopathy Severity Scale ranges from Level 10 (DR absent) to Level 65 (moderate proliferative diabetic retinopathy [PDR]), with a total of 12 levels based on the number of letters read incorrectly. Less than Level 47= mild to moderate nonproliferative diabetic retinopathy (NPDR). Level 47= moderately severe NPDR. Level 53=severe NPDR. Each level represents a change in DR (i.e., a change from Level 47 to >= Level 61 is >=2 steps worse).


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME)   [ Time Frame: 6 Months through 36 Months ]

2.  Primary:   Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye   [ Time Frame: Baseline, 36 Months ]

3.  Secondary:   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 ]

4.  Secondary:   First Occurrence of Focal/Grid Photocoagulation   [ Time Frame: Baseline through 36 Months ]

5.  Secondary:   Change From Baseline in Contrast Sensitivity by Pelli-Robson   [ Time Frame: Baseline, 36 Months ]

6.  Secondary:   Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography   [ Time Frame: Baseline through 36 Months ]

7.  Secondary:   Change From Baseline in Estimated Glomerular Filtration Rate   [ Time Frame: Baseline, 36 Months ]

8.  Secondary:   Change From Baseline at Endpoint in Albumin/Creatinine Ratio   [ Time Frame: 36 Months ]

9.  Secondary:   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 ]

10.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: Baseline through 36 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: info@chroma-derm.com
Organization: Chromaderm
e-mail: info@chroma-derm.com


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 ( Other Identifier: Eli Lilly and Company )
Study First Received: August 26, 2004
Results First Received: December 22, 2015
Last Updated: August 25, 2016
Health Authority: United States: Food and Drug Administration