Intravitreal Ranibizumab 0.5MG, or 1.0mg for RVO With Macular Edema Previously Receiving Bevacizumab (RAVEN)

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Hanscom, Thomas, M.D.
ClinicalTrials.gov Identifier:
NCT01471691
First received: November 9, 2011
Last updated: April 10, 2015
Last verified: April 2015
Results First Received: March 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Branch Retinal Vein Occlusion
Central Retinal Vein Occlusion
Macular Edema
Interventions: Drug: ranibizumab 0.5mg
Drug: ranibizumab 1.0mg

  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
No text entered.

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
Intravitreal Ranibizumab 0.5mg ranibizumab 0.5mg: Standard dose Patients were given six months of monthly treatment with the standard 0.5mg ranibizumab dose, followed by six months of evaluation and PRN treatment based upon pre-specified criteria.
Intravitreal Ranibizumab 1.0mg ranibizumab 1.0mg: High dose Patients were given six months of monthly treatment with the 1.0mg ranibizumab dose, followed by six months of evaluation and PRN treatment based upon pre-specified criteria.

Participant Flow:   Overall Study
    Intravitreal Ranibizumab 0.5mg     Intravitreal Ranibizumab 1.0mg  
STARTED     8     6  
COMPLETED     8     5  
NOT COMPLETED     0     1  
Lack of Efficacy                 0                 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
Intravitreal Ranibizumab 0.5mg ranibizumab 0.5mg: Standard dose
Intravitreal Ranibizumab 1.0mg ranibizumab 1.0mg: High dose
Total Total of all reporting groups

Baseline Measures
    Intravitreal Ranibizumab 0.5mg     Intravitreal Ranibizumab 1.0mg     Total  
Number of Participants  
[units: participants]
  8     6     14  
Age  
[units: years]
Mean (Standard Deviation)
  73  (5.0)     78  (5.0)     75  (5.0)  
Gender  
[units: participants]
     
Female     7     2     9  
Male     1     4     5  
Region of Enrollment  
[units: participants]
     
United States     8     6     14  



  Outcome Measures

1.  Primary:   Mean Change From Baseline BCVA   [ Time Frame: Baseline to month 6 ]

2.  Secondary:   Mean Change From Baseline in Center Point Thickness   [ Time Frame: months 1-12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Change in Mean Best Corrected Visual Acuity From Baseline   [ Time Frame: months 1-12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Percentage of Patients With CFT Less Than 300um   [ Time Frame: Month 6 and 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Excess Foveal Thickness   [ Time Frame: Month 6 and 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Total Number of Ranibizumab Injections   [ Time Frame: month 12 ]
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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Thomas O'Hearn MD
Organization: Thomas Hanscom AMC
phone: 310-829-3303
e-mail: tohearn@gmail.com


No publications provided


Responsible Party: Hanscom, Thomas, M.D.
ClinicalTrials.gov Identifier: NCT01471691     History of Changes
Other Study ID Numbers: ML27847
Study First Received: November 9, 2011
Results First Received: March 17, 2015
Last Updated: April 10, 2015
Health Authority: United States: Food and Drug Administration