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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)

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.
ClinicalTrials.gov Identifier: NCT00486018
Recruitment Status : Completed
First Posted : June 13, 2007
Results First Posted : February 25, 2011
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (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
Enrollment 397

Recruitment Details 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  
Arm/Group Title Sham Injection Ranibizumab Injection 0.3 mg Ranibizumab Injection 0.5 mg
Hide Arm/Group Description 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 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 in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
Period Title: Overall Study
Started 132 134 131
Received Drug (Safety Population) 131 134 130
Completed 123 128 125
Not Completed 9 6 6
Arm/Group Title Sham Injection Ranibizumab Injection 0.3 mg Ranibizumab Injection 0.5 mg Total
Hide Arm/Group Description 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 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 in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections. Total of all reporting groups
Overall Number of Baseline Participants 132 134 131 397
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 132 participants 134 participants 131 participants 397 participants
65.2  (12.7) 66.6  (11.2) 67.5  (11.8) 66.4  (11.9)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 132 participants 134 participants 131 participants 397 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants 134 participants 131 participants 397 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%
1.Primary Outcome
Title Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months
Hide Description BCVA score in the study eye was based on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (randomized) population. Missing values were imputed using the last-observation-carried-forward (LOCF) method.
Arm/Group Title Sham Injection Ranibizumab Injection 0.3 mg Ranibizumab Injection 0.5 mg
Hide Arm/Group Description:
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 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 in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
Overall Number of Participants Analyzed 132 134 131
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 54.7  (12.2) 56.0  (12.1) 53.0  (12.5)
Change from Baseline at Month 6 7.3  (13.0) 16.6  (11.0) 18.3  (13.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Injection, Ranibizumab Injection 0.3 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The Hochberg–Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.
Method ANOVA
Comments Stratified by baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters).
Method of Estimation Estimation Parameter Difference in Least Squares means
Estimated Value 9.4
Confidence Interval 95%
6.6 to 12.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Injection, Ranibizumab Injection 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.
Method ANOVA
Comments Stratified by baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters).
Method of Estimation Estimation Parameter Difference in Least Squares means
Estimated Value 10.6
Confidence Interval 95%
7.6 to 13.6
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With Baseline
Hide Description BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (randomized) population. Missing values were imputed using the LOCF method.
Arm/Group Title Sham Injection Ranibizumab Injection 0.3 mg Ranibizumab Injection 0.5 mg
Hide Arm/Group Description:
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 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 in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
Overall Number of Participants Analyzed 132 134 131
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
28.8
(21.1 to 36.5)
55.2
(46.8 to 63.6)
61.1
(52.7 to 69.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Injection, Ranibizumab Injection 0.3 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel χ²
Comments Stratified by baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters).
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 26.8
Confidence Interval 95%
15.6 to 38.0
Estimation Comments Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters) using Cochran–Mantel–Haenszel weights.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Injection, Ranibizumab Injection 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel χ²
Comments Stratified by baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters).
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 31.3
Confidence Interval 95%
20.1 to 42.6
Estimation Comments Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.
3.Secondary Outcome
Title Percentage of Participants Who Lost < 15 Letters in BCVA Score at Month 6 Compared With Baseline
Hide Description BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters. The percentage of subjects who lost <15 letters will be greater than the percentage of subjects who “gained >=15 letters” as “losing <15 letters” includes both those who gained >=15 letters and those who were “stable” (i.e. lost between 1 and 14 letters, had no change, or gained between 1 and 14 letters).
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (randomized) population. Missing values were imputed using the LOCF method.
Arm/Group Title Sham Injection Ranibizumab Injection 0.3 mg Ranibizumab Injection 0.5 mg
Hide Arm/Group Description:
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 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 in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
Overall Number of Participants Analyzed 132 134 131
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
95.5
(90.5 to 98.0)
100
(97.4 to 100)
98.5
(94.6 to 99.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Injection, Ranibizumab Injection 0.3 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0141
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 4.5
Confidence Interval 95%
1.6 to 9.9
Estimation Comments Exact confidence interval based on inverting the exact two-sided score test.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Injection, Ranibizumab Injection 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2815
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 3.0
Confidence Interval 95%
-1.5 to 8.3
Estimation Comments Exact confidence interval based on inverting the exact two-sided score test.
4.Secondary Outcome
Title Percentage of Participants With a Central Foveal Thickness of ≤ 250 μm at Month 6
Hide Description A central reading center assessed all optical coherence tomography (OCT) images. Central foveal thickness was defined as the center point thickness.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (randomized) population. Missing values were imputed using the LOCF method.
Arm/Group Title Sham Injection Ranibizumab Injection 0.3 mg Ranibizumab Injection 0.5 mg
Hide Arm/Group Description:
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 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 in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
Overall Number of Participants Analyzed 132 134 131
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
45.5
(37.0 to 53.9)
91.0
(86.2 to 95.9)
84.7
(78.6 to 90.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Injection, Ranibizumab Injection 0.3 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel χ²
Comments Stratified by baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters).
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 45.5
Confidence Interval 95%
36.0 to 55.0
Estimation Comments Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters) using Cochran–Mantel–Haenszel weights.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Injection, Ranibizumab Injection 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel χ²
Comments Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 40.1
Confidence Interval 95%
29.9 to 50.2
Estimation Comments Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.
5.Secondary Outcome
Title Mean Absolute Change From Baseline in Central Foveal Thickness at Month 6
Hide Description A central reading center assessed all OCT images. Central foveal thickness was defined as the center point thickness.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (randomized) population. Missing values were imputed using the LOCF method.
Arm/Group Title Sham Injection Ranibizumab Injection 0.3 mg Ranibizumab Injection 0.5 mg
Hide Arm/Group Description:
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 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 in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
Overall Number of Participants Analyzed 132 134 131
Mean (Standard Deviation)
Unit of Measure: μm
Baseline 488.0  (192.2) 522.1  (201.9) 551.7  (223.5)
Mean Absolute Change from Baseline at Month 6 -157.7  (224.2) -337.3  (224.4) -345.2  (238.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Injection, Ranibizumab Injection 0.3 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters) and baseline value of central foveal thickness.
Method of Estimation Estimation Parameter Difference in Least Squares means
Estimated Value -148.7
Confidence Interval 95%
-183.6 to -113.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Injection, Ranibizumab Injection 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters) and baseline value of central foveal thickness.
Method of Estimation Estimation Parameter Difference in Least Squares means
Estimated Value -134.8
Confidence Interval 95%
-172.7 to -96.8
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Near Activities Subscale Score at Month 6
Hide Description The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A3, A4, and A5 pertained to the Near Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.
Arm/Group Title Sham Injection Ranibizumab Injection 0.3 mg Ranibizumab Injection 0.5 mg
Hide Arm/Group Description:
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 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 in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
Overall Number of Participants Analyzed 129 133 130
Mean (Standard Deviation)
Unit of Measure: Points on the NEI VFQ-25 subscale
Baseline 69.6  (20.2) 67.9  (22.1) 69.4  (20.5)
Change from baseline at Month 6 7.3  (15.3) 12.1  (17.3) 13.7  (18.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Injection, Ranibizumab Injection 0.3 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0214
Comments [Not Specified]
Method ANCOVA
Comments Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters) and baseline Near Activities Subscale score.
Method of Estimation Estimation Parameter Difference in Least Squares means
Estimated Value 4.1
Confidence Interval 95%
0.6 to 7.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Injection, Ranibizumab Injection 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANCOVA
Comments Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters) and baseline Near Activities Subscale score.
Method of Estimation Estimation Parameter Difference in Least Squares means
Estimated Value 6.4
Confidence Interval 95%
3.0 to 9.8
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6
Hide Description The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A6, A7, and A8 pertained to the Distance Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.
Arm/Group Title Sham Injection Ranibizumab Injection 0.3 mg Ranibizumab Injection 0.5 mg
Hide Arm/Group Description:
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 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 in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
Overall Number of Participants Analyzed 129 133 130
Mean (Standard Deviation)
Unit of Measure: Points on the NEI-VFQ-25 subscale
Baseline 76.4  (20.6) 76.0  (20.5) 76.7  (18.1)
Mean Change from Baseline at Month 6 6.3  (15.0) 10.3  (17.2) 11.3  (16.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Injection, Ranibizumab Injection 0.3 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0248
Comments [Not Specified]
Method ANCOVA
Comments Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters) and baseline Distance Activities Subscale score.
Method of Estimation Estimation Parameter Difference in Least Squares means
Estimated Value 3.8
Confidence Interval 95%
0.5 to 7.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Injection, Ranibizumab Injection 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method ANCOVA
Comments Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters) and baseline Distance Activities Subscale score.
Method of Estimation Estimation Parameter Difference in Least Squares means
Estimated Value 5.1
Confidence Interval 95%
2.0 to 8.3
Estimation Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting 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.
 
Arm/Group Title Sham Injection Ranibizumab Injection 0.3 mg Ranibizumab Injection 0.5 mg
Hide Arm/Group Description 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 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 in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
All-Cause Mortality
Sham Injection Ranibizumab Injection 0.3 mg Ranibizumab Injection 0.5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sham Injection Ranibizumab Injection 0.3 mg Ranibizumab Injection 0.5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/131 (4.58%)   14/134 (10.45%)   14/130 (10.77%) 
Cardiac disorders       
Acute Myocardial Infarction  1  0/131 (0.00%)  0/134 (0.00%)  1/130 (0.77%) 
Angina Unstable  1  0/131 (0.00%)  0/134 (0.00%)  1/130 (0.77%) 
Bradycardia  1  0/131 (0.00%)  0/134 (0.00%)  1/130 (0.77%) 
Ear and labyrinth disorders       
Vertigo  1  0/131 (0.00%)  1/134 (0.75%)  0/130 (0.00%) 
Eye disorders       
Glaucoma  1  0/131 (0.00%)  1/134 (0.75%)  0/130 (0.00%) 
Gaze Palsy  1  0/131 (0.00%)  0/134 (0.00%)  1/130 (0.77%) 
Visual Acuity Reduced  1  0/131 (0.00%)  1/134 (0.75%)  0/130 (0.00%) 
Retinal Ischemia  1  0/131 (0.00%)  1/134 (0.75%)  0/130 (0.00%) 
Retinal Neovascularization  1  1/131 (0.76%)  0/134 (0.00%)  0/130 (0.00%) 
Retinal Vein Occlusion  1  0/131 (0.00%)  0/134 (0.00%)  1/130 (0.77%) 
Retinal Detachment  1  0/131 (0.00%)  1/134 (0.75%)  0/130 (0.00%) 
Retinal Tear  1  0/131 (0.00%)  1/134 (0.75%)  0/130 (0.00%) 
Macular Edema  1  1/131 (0.76%)  0/134 (0.00%)  0/130 (0.00%) 
Gastrointestinal disorders       
Colonic Polyp  1  0/131 (0.00%)  0/134 (0.00%)  1/130 (0.77%) 
Small Intestinal Obstruction  1  0/131 (0.00%)  1/134 (0.75%)  1/130 (0.77%) 
Intra-Abdominal Hematoma  1  0/131 (0.00%)  1/134 (0.75%)  0/130 (0.00%) 
Rectal Hemorrhage  1  0/131 (0.00%)  1/134 (0.75%)  0/130 (0.00%) 
Intestinal Perforation  1  0/131 (0.00%)  0/134 (0.00%)  1/130 (0.77%) 
Hepatobiliary disorders       
Cholecystitis  1  0/131 (0.00%)  1/134 (0.75%)  0/130 (0.00%) 
Infections and infestations       
Cellulitis  1  0/131 (0.00%)  0/134 (0.00%)  1/130 (0.77%) 
Osteomyelitis  1  0/131 (0.00%)  1/134 (0.75%)  0/130 (0.00%) 
Endophthalmitis  1  0/131 (0.00%)  0/134 (0.00%)  1/130 (0.77%) 
Lobar Pneumonia  1  0/131 (0.00%)  1/134 (0.75%)  0/130 (0.00%) 
Pneumonia  1  1/131 (0.76%)  2/134 (1.49%)  0/130 (0.00%) 
Sinusitis  1  0/131 (0.00%)  1/134 (0.75%)  0/130 (0.00%) 
Urinary Tract Infection  1  1/131 (0.76%)  0/134 (0.00%)  0/130 (0.00%) 
Gastroenteritis Viral  1  0/131 (0.00%)  1/134 (0.75%)  0/130 (0.00%) 
Injury, poisoning and procedural complications       
Corneal Abrasion  1  0/131 (0.00%)  1/134 (0.75%)  0/130 (0.00%) 
Post Procedural Hemorrhage  1  0/131 (0.00%)  0/134 (0.00%)  1/130 (0.77%) 
Pelvic Fracture  1  1/131 (0.76%)  0/134 (0.00%)  0/130 (0.00%) 
Metabolism and nutrition disorders       
Diabetes Mellitus  1  0/131 (0.00%)  0/134 (0.00%)  1/130 (0.77%) 
Dehydration  1  0/131 (0.00%)  0/134 (0.00%)  1/130 (0.77%) 
Musculoskeletal and connective tissue disorders       
Arthritis  1  0/131 (0.00%)  1/134 (0.75%)  0/130 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Gastric Cancer  1  0/131 (0.00%)  0/134 (0.00%)  1/130 (0.77%) 
Nervous system disorders       
Cerebral Hemorrhage  1  0/131 (0.00%)  0/134 (0.00%)  1/130 (0.77%) 
Thalamus Hemorrhage  1  1/131 (0.76%)  0/134 (0.00%)  0/130 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Chronic Obstructive Pulmonary Disease  1  1/131 (0.76%)  0/134 (0.00%)  0/130 (0.00%) 
Pleural Effusion  1  0/131 (0.00%)  0/134 (0.00%)  1/130 (0.77%) 
Vascular disorders       
Hypertension  1  0/131 (0.00%)  2/134 (1.49%)  0/130 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sham Injection Ranibizumab Injection 0.3 mg Ranibizumab Injection 0.5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   115/131 (87.79%)   125/134 (93.28%)   115/130 (88.46%) 
Eye disorders       
Conjunctival Hemorrhage  1  55/131 (41.98%)  80/134 (59.70%)  71/130 (54.62%) 
Eye Irritation  1  10/131 (7.63%)  8/134 (5.97%)  8/130 (6.15%) 
Eye Pain  1  19/131 (14.50%)  33/134 (24.63%)  21/130 (16.15%) 
Foreign Body Sensation in Eyes  1  8/131 (6.11%)  6/134 (4.48%)  9/130 (6.92%) 
Maculopathy  1  11/131 (8.40%)  16/134 (11.94%)  16/130 (12.31%) 
Myodesopsia  1  2/131 (1.53%)  17/134 (12.69%)  6/130 (4.62%) 
Ocular Hyperemia  1  6/131 (4.58%)  13/134 (9.70%)  8/130 (6.15%) 
Ocular Vascular Disorder  1  16/131 (12.21%)  21/134 (15.67%)  10/130 (7.69%) 
Retinal Depigmentation  1  6/131 (4.58%)  6/134 (4.48%)  15/130 (11.54%) 
Retinal Exudates  1  20/131 (15.27%)  37/134 (27.61%)  32/130 (24.62%) 
Retinal Hemorrhage  1  18/131 (13.74%)  23/134 (17.16%)  23/130 (17.69%) 
Retinal Vascular Disorder  1  9/131 (6.87%)  10/134 (7.46%)  15/130 (11.54%) 
Vision Blurred  1  5/131 (3.82%)  5/134 (3.73%)  8/130 (6.15%) 
Vitreous Detachment  1  3/131 (2.29%)  8/134 (5.97%)  5/130 (3.85%) 
Infections and infestations       
Nasopharyngitis  1  7/131 (5.34%)  6/134 (4.48%)  7/130 (5.38%) 
Sinusitis  1  4/131 (3.05%)  10/134 (7.46%)  5/130 (3.85%) 
Investigations       
Intraocular Pressure Increased  1  3/131 (2.29%)  7/134 (5.22%)  9/130 (6.92%) 
Nervous system disorders       
Dizziness  1  7/131 (5.34%)  5/134 (3.73%)  0/130 (0.00%) 
Headache  1  6/131 (4.58%)  9/134 (6.72%)  3/130 (2.31%) 
Vascular disorders       
Hypertension  1  12/131 (9.16%)  11/134 (8.21%)  10/130 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Medical Communications
Organization: Genentech, Inc.
Phone: 800-821-8590
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00486018     History of Changes
Other Study ID Numbers: FVF4165g
First Submitted: June 11, 2007
First Posted: June 13, 2007
Results First Submitted: August 16, 2010
Results First Posted: February 25, 2011
Last Update Posted: May 10, 2017