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Ranibizumab for Treatment of Persistent Diabetic Neovascularization Assessed by Wide-Field Imaging

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00606138
First received: January 9, 2008
Last updated: November 4, 2014
Last verified: November 2014
Results First Received: December 7, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Proliferative Diabetic Retinopathy
Interventions: Drug: ranibizumab
Procedure: Laser photocoagulation

  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
Subjects will be recruited starting in 2007 and until sufficient subject population is reached. They will be seen in an eye clinic at Rush University Medical Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There is no wash-out period. Recruited subjects must be in need of treatment for their PDR, and will be randomized and treated at the baseline visit.

Reporting Groups
  Description
1 - Ranibizumab Intravitreal injection of 0.5-mg dose of ranibizumab
2 - Additional PRP Treatment Additional panretinal photocoagulation (up to 500 300-500 um laser spots)

Participant Flow:   Overall Study
    1 - Ranibizumab     2 - Additional PRP Treatment  
STARTED     6     2  
COMPLETED     6     2  
NOT COMPLETED     0     0  



  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.
No text entered.

Reporting Groups
  Description
1 - Ranibizumab Intravitreal injection of 0.5-mg dose of ranibizumab
2 - Additional PRP Treatment Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
Total Total of all reporting groups

Baseline Measures
    1 - Ranibizumab     2 - Additional PRP Treatment     Total  
Number of Participants  
[units: participants]
  6     2     8  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     6     1     7  
>=65 years     0     1     1  
Age  
[units: years]
Median ( Full Range )
  57  
  ( 50 to 62 )  
  67  
  ( 60 to 73 )  
  59  
  ( 50 to 73 )  
Gender  
[units: participants]
     
Female     1     1     2  
Male     5     1     6  
Region of Enrollment  
[units: participants]
     
United States     6     2     8  



  Outcome Measures
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1.  Primary:   The Mean Percentage Change of the Area of the Patient's Neovascularization as Measured in Pixels by Optomap FA (Fluorescein Angiography)   [ Time Frame: Week 4; Month 6 ]

2.  Primary:   The Mean Percentage Change of Macular Edema Measured by Retinal Thickness by OCT (Optical Coherence Tomography)   [ Time Frame: Week 4; Month 6 ]

3.  Primary:   Incidence and Severity of Ocular Adverse Events, as Identified by Ophthalmic Examination   [ Time Frame: Month 6 ]

4.  Secondary:   Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters   [ Time Frame: Week 4; Month 6 ]

5.  Secondary:   Occurrence Rate of Proliferative Diabetic Complications Including Vitreous Hemorrhage, Iris Neovascularization, and Tractional Retinal Detachment   [ Time Frame: Month 6 ]

6.  Primary:   Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs   [ Time Frame: Week 1, 2, 4; Month 2, 3, 4, 5, 6 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

7.  Secondary:   Percentage of Patients Gaining 3 or More Lines of Vision According to ETDRS Eye Chart Testing   [ Time Frame: Week 1, 2, 4; Month 2, 3, 4, 5, 6 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Mathew MacCumber, MD, PhD
Organization: Rush University Medical Center
phone: 312-563-4032
e-mail: denise_voskuil-marre@rush.edu


No publications provided


Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00606138     History of Changes
Other Study ID Numbers: 06120402
Study First Received: January 9, 2008
Results First Received: December 7, 2012
Last Updated: November 4, 2014
Health Authority: United States: Food and Drug Administration