Ranibizumab 0.5mg and 2.0mg to Treat Diabetic Macular Edema in Patients With Poor Response to Bevacizumab (REEF)

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
California Retina Consultants
ClinicalTrials.gov Identifier:
NCT01292798
First received: February 7, 2011
Last updated: March 23, 2016
Last verified: March 2016
Results First Received: January 27, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetic Macular Edema
Intervention: Drug: Ranibizumab

  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
2.0 mg Ranibizumab Subjects who presented with persistent DME at month 3 following 3 months of monthly 0.5 mg ranibizumab injections received 3 monthly injections of 2.0 mg Ranibizumab.

Participant Flow:   Overall Study
    2.0 mg Ranibizumab  
STARTED     43  
Persistent DME After 3 Months     29 [1]
COMPLETED     43  
NOT COMPLETED     0  
[1] Subjects with persistent DME after 3 monthly injections of 0.5 mg of ranibizumab



  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
2.0 mg Ranibizumab Subjects who presented with persistent DME at month 3 following 3 months of monthly 0.5 mg ranibizumab injections received 3 monthly injections of 2.0 mg Ranibizumab.

Baseline Measures
    2.0 mg Ranibizumab  
Number of Participants  
[units: participants]
  43  
Age  
[units: years]
Mean (Standard Deviation)
  64.0  (10.1)  
Gender  
[units: participants]
 
Female     20  
Male     23  
Region of Enrollment  
[units: participants]
 
United States     43  



  Outcome Measures
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1.  Primary:   Overall Mean Change in Visual Acuity Scores at Month 6 Compared to Baseline   [ Time Frame: baseline and 6 months ]

2.  Secondary:   Mean Change in 1-mm Central Subfield (CST) Thickness as Measured by OCT at Month 6 Compared to Baseline   [ Time Frame: baseline and 6 months ]

3.  Secondary:   Qualitative Assessment of Diabetic Macular Edema (DME)   [ Time Frame: Baeline and 6 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Director of Research
Organization: California Retina Consultants
phone: 8059631648 ext 3034
e-mail: gabe@californiaretina.com


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

Responsible Party: California Retina Consultants
ClinicalTrials.gov Identifier: NCT01292798     History of Changes
Other Study ID Numbers: FVF4978s
Study First Received: February 7, 2011
Results First Received: January 27, 2016
Last Updated: March 23, 2016
Health Authority: United States: Food and Drug Administration