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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:
ClinicalTrials.gov Identifier:
NCT01247220
First Posted: November 24, 2010
Last Update Posted: October 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ivan J. Suner, MD, Retina Associates of Florida, P.A.
Results First Submitted: October 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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



Responsible Party: Ivan J. Suner, MD, Retina Associates of Florida, P.A.
ClinicalTrials.gov Identifier: NCT01247220     History of Changes
Other Study ID Numbers: 20101717
First Submitted: November 17, 2010
First Posted: November 24, 2010
Results First Submitted: October 1, 2014
Results First Posted: October 6, 2014
Last Update Posted: October 6, 2014