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

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00486018
First received: June 11, 2007
Last updated: April 25, 2011
Last verified: April 2011
Results First Received: August 16, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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
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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.
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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  
Number of Participants  
[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  
Gender  
[units: participants]
       
Female     58     67     60     185  
Male     74     67     71     212  



  Outcome Measures
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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
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Time Frame 6 months
Additional Description Investigators assessed the occurrence of AE/SAEs at all study visits. Summaries are for the safety-evaluable population and include events regardless of relation to study drug or location (e.g. non-study eye events are included). For each AE/SAE, the number of patients experiencing the event, not the number of occurrences of the event, is reported.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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.

Other Adverse Events
    Sham Injection     Ranibizumab Injection 0.3 mg     Ranibizumab Injection 0.5 mg  
Total, other (not including serious) adverse events        
# participants affected / at risk     115/131     125/134     115/130  
Eye disorders        
Conjunctival Hemorrhage † 1      
# participants affected / at risk     55/131 (41.98%)     80/134 (59.70%)     71/130 (54.62%)  
Eye Irritation † 1      
# participants affected / at risk     10/131 (7.63%)     8/134 (5.97%)     8/130 (6.15%)  
Eye Pain † 1      
# participants affected / at risk     19/131 (14.50%)     33/134 (24.63%)     21/130 (16.15%)  
Foreign Body Sensation in Eyes † 1      
# participants affected / at risk     8/131 (6.11%)     6/134 (4.48%)     9/130 (6.92%)  
Maculopathy † 1      
# participants affected / at risk     11/131 (8.40%)     16/134 (11.94%)     16/130 (12.31%)  
Myodesopsia † 1      
# participants affected / at risk     2/131 (1.53%)     17/134 (12.69%)     6/130 (4.62%)  
Ocular Hyperemia † 1      
# participants affected / at risk     6/131 (4.58%)     13/134 (9.70%)     8/130 (6.15%)  
Ocular Vascular Disorder † 1      
# participants affected / at risk     16/131 (12.21%)     21/134 (15.67%)     10/130 (7.69%)  
Retinal Depigmentation † 1      
# participants affected / at risk     6/131 (4.58%)     6/134 (4.48%)     15/130 (11.54%)  
Retinal Exudates † 1      
# participants affected / at risk     20/131 (15.27%)     37/134 (27.61%)     32/130 (24.62%)  
Retinal Hemorrhage † 1      
# participants affected / at risk     18/131 (13.74%)     23/134 (17.16%)     23/130 (17.69%)  
Retinal Vascular Disorder † 1      
# participants affected / at risk     9/131 (6.87%)     10/134 (7.46%)     15/130 (11.54%)  
Vision Blurred † 1      
# participants affected / at risk     5/131 (3.82%)     5/134 (3.73%)     8/130 (6.15%)  
Vitreous Detachment † 1      
# participants affected / at risk     3/131 (2.29%)     8/134 (5.97%)     5/130 (3.85%)  
Infections and infestations        
Nasopharyngitis † 1      
# participants affected / at risk     7/131 (5.34%)     6/134 (4.48%)     7/130 (5.38%)  
Sinusitis † 1      
# participants affected / at risk     4/131 (3.05%)     10/134 (7.46%)     5/130 (3.85%)  
Investigations        
Intraocular Pressure Increased † 1      
# participants affected / at risk     3/131 (2.29%)     7/134 (5.22%)     9/130 (6.92%)  
Nervous system disorders        
Dizziness † 1      
# participants affected / at risk     7/131 (5.34%)     5/134 (3.73%)     0/130 (0.00%)  
Headache † 1      
# participants affected / at risk     6/131 (4.58%)     9/134 (6.72%)     3/130 (2.31%)  
Vascular disorders        
Hypertension † 1      
# participants affected / at risk     12/131 (9.16%)     11/134 (8.21%)     10/130 (7.69%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (12.0)



  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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