Ranibizumab (Lucentis) for Macular Edema Secondary to Vein Occlusions (LVO)

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Peter A Campochiaro, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00407355
First received: December 1, 2006
Last updated: October 7, 2013
Last verified: October 2013
Results First Received: October 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Macular Edema
Retinal Vein Occlusion
Interventions: Drug: Intravitreal injection of ranibizumab .3 dose
Drug: Intravitreal injection of Ranibizumab .5 dose

  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
20 patients with central retinal vein occlusion(CRVO) and 20 patients with branch retinal vein occlusion (BRVO) were enrolled at the Wilmer Eye Institute

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None

Reporting Groups
  Description
CRVO 10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
BRVO 10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years

Participant Flow:   Overall Study
    CRVO     BRVO  
STARTED     20     20  
COMPLETED     10     9  
NOT COMPLETED     10     11  



  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
CRVO 10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
BRVO 10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
Total Total of all reporting groups

Baseline Measures
    CRVO     BRVO     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     9     18  
>=65 years     11     11     22  
Age  
[units: years]
Mean ± Standard Deviation
  63.9  ± 15.7     67.4  ± 11.3     67.1  ± 12.5  
Gender  
[units: participants]
     
Female     7     11     18  
Male     13     9     22  
Region of Enrollment  
[units: participants]
     
United States     20     20     40  



  Outcome Measures
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1.  Primary:   Best Corrected Visual Acuity Change From Baseline at All Visits   [ Time Frame: continuous through 72 mos ]

2.  Primary:   Retinal Thickness Change From Baseline at All Visits   [ Time Frame: continuous through 72 mos ]


  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


No publications provided by Johns Hopkins University

Publications automatically indexed to this study:

Responsible Party: Peter A Campochiaro, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00407355     History of Changes
Other Study ID Numbers: 05-06-09-05
Study First Received: December 1, 2006
Results First Received: October 7, 2013
Last Updated: October 7, 2013
Health Authority: United States: Food and Drug Administration