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Extended Follow-up of Patients With Macular Edema Due to Retinal Vein Occlusion (RETAIN)

This study has been completed.
Sponsor:
Collaborators:
The Macula Foundation, Inc.
Genentech, Inc.
Information provided by (Responsible Party):
Peter A Campochiaro, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01198327
First received: August 31, 2010
Last updated: November 27, 2013
Last verified: November 2013
Results First Received: September 23, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Retinal Vein Occlusion
Interventions: Drug: ranibizumab
Other: Peripheral Laser

  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
66 retinal vein occlusion patients from the HORIZON study(NCT01198327)were enrolled from 7 sites for long term follow up. The sites were: Wilmer Eye Institute, Ophthalmic Consultants of Boston, Retina Consultants of New Jersey, Retina Consultants Macula Group,Retina Consultants of Houston, Southeast Retina and Retina Vitreous Associates

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
Ranibizumab as Needed Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.

Participant Flow:   Overall Study
    Ranibizumab as Needed  
STARTED     66  
COMPLETED     56  
NOT COMPLETED     10  



  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
Ranibizumab as Needed Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.

Baseline Measures
    Ranibizumab as Needed  
Number of Participants  
[units: participants]
  66  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     23  
>=65 years     43  
Age  
[units: years]
Mean ± Standard Deviation
  67.9  ± 10.8  
Gender  
[units: participants]
 
Female     28  
Male     38  
Region of Enrollment  
[units: participants]
 
United States     66  



  Outcome Measures
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1.  Primary:   Incidence of Serious Adverse Events.   [ Time Frame: 24 mos ]

2.  Secondary:   Mean Changes in Visual Acuity   [ Time Frame: 24 mos from study baseline ]

3.  Secondary:   Mean Change in Retinal Thickness   [ Time Frame: 24 mos from study baseline ]


  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 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: Peter Campocahiro
Organization: Wilmer Eye Institute
phone: 410-955-5106
e-mail: pcampo@jhmi.edu


Publications:

Responsible Party: Peter A Campochiaro, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01198327     History of Changes
Other Study ID Numbers: NA_00040287
Study First Received: August 31, 2010
Results First Received: September 23, 2013
Last Updated: November 27, 2013
Health Authority: United States: Food and Drug Administration