Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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:
Genentech, Inc.
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Gender 
[Units: Participants]
       
Female   58   67   60   185 
Male   74   67   71   212 


  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
  Hide Other Adverse Events

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 (87.79%)   125/134 (93.28%)   115/130 (88.46%) 
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
  Hide Limitations and Caveats

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
No text entered.


  More Information