Reduction in the Occurrence of Center-Involved Diabetic Macular Edema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00090519
First received: August 26, 2004
Last updated: May 13, 2016
Last verified: May 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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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
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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.
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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  
Number of Participants  
[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)  
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 [2]
[units: participants]
     
Type 1     85     76     161  
Type 2     286     284     570  
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) [3]
[units: Letters read correctly]
Mean (Standard Deviation)
  84.12  (7.93)     84.27  (7.70)     84.19  (7.81)  
Diabetic Retinopathy (DR) Level [4]
[units: DR study eyes for each level]
     
<47     465     421     886  
47     250     272     522  
53     7     3     10  
[1] Body mass index is an estimate of body fat based on body weight divided by height squared.
[2] 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.
[3] 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.
[4] 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
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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
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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
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  More Information
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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: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eli Lilly and Company
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: May 13, 2016
Health Authority: United States: Food and Drug Administration