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A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRAVO) (BRAVO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00486018
First received: June 11, 2007
Last updated: April 4, 2017
Last verified: April 2017
Results First Received: August 16, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Conditions: Macular Edema
Retinal Vein Occlusion
Interventions: Drug: Ranibizumab injection 0.3 mg
Drug: Ranibizumab injection 0.5 mg
Drug: Sham injection

  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
Please note that although the table below is titled "Overall Study," the completion rates are for the 6-month Treatment Period only (i.e., does not include the 6-month Observation Period data).

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
Sham Injection Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
Ranibizumab Injection 0.3 mg Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
Ranibizumab Injection 0.5 mg Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.

Participant Flow:   Overall Study
    Sham Injection   Ranibizumab Injection 0.3 mg   Ranibizumab Injection 0.5 mg
STARTED   132   134   131 
Received Drug (Safety Population)   131   134   130 
COMPLETED   123   128   125 
NOT COMPLETED   9   6   6 



  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
Sham Injection Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
Ranibizumab Injection 0.3 mg Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
Ranibizumab Injection 0.5 mg Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
Total Total of all reporting groups

Baseline Measures
   Sham Injection   Ranibizumab Injection 0.3 mg   Ranibizumab Injection 0.5 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 132   134   131   397 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.2  (12.7)   66.6  (11.2)   67.5  (11.8)   66.4  (11.9) 
Age, Customized 
[Units: Participants]
       
< 45 years   8   5   4   17 
45 to < 65 years   59   51   51   161 
65 to < 85 years   60   74   69   203 
≥ 85 years   5   4   7   16 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      58  43.9%      67  50.0%      60  45.8%      185  46.6% 
Male      74  56.1%      67  50.0%      71  54.2%      212  53.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months   [ Time Frame: Baseline and 6 months ]

2.  Secondary:   Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With Baseline   [ Time Frame: Baseline and 6 months ]

3.  Secondary:   Percentage of Participants Who Lost < 15 Letters in BCVA Score at Month 6 Compared With Baseline   [ Time Frame: Baseline and 6 months ]

4.  Secondary:   Percentage of Participants With a Central Foveal Thickness of ≤ 250 μm at Month 6   [ Time Frame: 6 months ]

5.  Secondary:   Mean Absolute Change From Baseline in Central Foveal Thickness at Month 6   [ Time Frame: Baseline and 6 months ]

6.  Secondary:   Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Near Activities Subscale Score at Month 6   [ Time Frame: Baseline and 6 months ]

7.  Secondary:   Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6   [ Time Frame: Baseline and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information