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REtinal Vein OccLUsion Treatment With Scatter Laser Guided by UWFA in combiNAtion With Ranibizumab Study (Revolution)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ivan J. Suner, MD, Retina Associates of Florida, P.A.
ClinicalTrials.gov Identifier:
NCT01247220
First received: November 17, 2010
Last updated: October 3, 2014
Last verified: October 2014
Results First Received: October 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Macular Edema
Branch Retinal Vein Occlusion
Interventions: Drug: Ranibizumab
Procedure: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Peripheral Laser + Ranibizumab

Angiography-directed peripheral laser + ranibizumab

Ranibizumab: Intravitreal Ranibizumab 0.5 mg

Peripheral Laser: Angiography-directed peripheral laser

Ranibizumab

Ranibizumab

Ranibizumab: Intravitreal Ranibizumab 0.5 mg


Participant Flow:   Overall Study
    Peripheral Laser + Ranibizumab     Ranibizumab  
STARTED     6     6  
COMPLETED     6     6  
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
Peripheral Laser + Ranibizumab

Angiography-directed peripheral laser + ranibizumab

Ranibizumab: Intravitreal Ranibizumab 0.5 mg

Peripheral Laser: Angiography-directed peripheral laser

Ranibizumab

Ranibizumab

Ranibizumab: Intravitreal Ranibizumab 0.5 mg

Total Total of all reporting groups

Baseline Measures
    Peripheral Laser + Ranibizumab     Ranibizumab     Total  
Number of Participants  
[units: participants]
  6     6     12  
Age  
[units: years]
Mean ± Standard Deviation
  69  ± 18     70  ± 10     69.5  ± 14  
Gender  
[units: participants]
     
Female     2     4     6  
Male     4     2     6  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     0     1  
White     5     6     11  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  



  Outcome Measures
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1.  Primary:   Visual Acuity   [ Time Frame: 6 and 12 months ]

2.  Secondary:   Number of Ranibizumab Injections   [ Time Frame: 12 months ]

3.  Secondary:   Retinal Thickness   [ Time Frame: 6 and 12 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
small study size


  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: Ivan J. Suner, MD
Organization: Retina Associates of Florida
phone: 813-875-6373
e-mail: ivansuner@gmail.com


No publications provided


Responsible Party: Ivan J. Suner, MD, Retina Associates of Florida, P.A.
ClinicalTrials.gov Identifier: NCT01247220     History of Changes
Other Study ID Numbers: 20101717
Study First Received: November 17, 2010
Results First Received: October 1, 2014
Last Updated: October 3, 2014
Health Authority: United States: Food and Drug Administration