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

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: NCT00485836
Recruitment Status : Completed
First Posted : June 13, 2007
Results First Posted : February 25, 2011
Last Update Posted : July 28, 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: Sham injection
Drug: Ranibizumab injection 0.3 mg
Drug: Ranibizumab injection 0.5 mg
Enrollment 392
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 130 132 130
Received Study Drug (Safety Population) 129 132 129
Completed 115 129 119
Not Completed 15 3 11
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 130 132 130 392
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 130 participants 132 participants 130 participants 392 participants
65.4  (13.1) 69.7  (11.6) 67.6  (12.4) 67.6  (12.5)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 130 participants 132 participants 130 participants 392 participants
< 45 years 10 5 5 20
45 to < 65 years 50 36 46 132
65 to < 85 years 67 80 71 218
≥ 85 years 3 11 8 22
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 132 participants 130 participants 392 participants
Female
58
  44.6%
61
  46.2%
50
  38.5%
169
  43.1%
Male
72
  55.4%
71
  53.8%
80
  61.5%
223
  56.9%
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
Hide 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 130 132 130
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 49.2  (14.7) 47.4  (14.8) 48.1  (14.6)
Mean Change from Baseline at Month 6 0.8  (16.2) 12.7  (15.9) 14.9  (13.2)
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 11.5
Confidence Interval 95%
7.7 to 15.3
Estimation Comments [Not Specified]
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 13.8
Confidence Interval 95%
10.3 to 17.4
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
Hide 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 130 132 130
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
16.9
(10.5 to 23.4)
46.2
(37.7 to 54.7)
47.7
(39.1 to 56.3)
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 29.3
Confidence Interval 95%
18.8 to 39.7
Estimation Comments Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.
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 30.3
Confidence Interval 95%
19.6 to 40.9
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.
Time Frame Baseline and 6 months
Hide 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 130 132 130
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
84.6
(78.4 to 90.8)
96.2
(93.0 to 99.5)
98.5
(96.3 to 100)
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 0.0019
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 11.3
Confidence Interval 95%
4.3 to 18.2
Estimation Comments Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.
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 13.6
Confidence Interval 95%
7.2 to 20.1
Estimation Comments Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.
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
Hide 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 130 132 130
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
23.1
(15.8 to 30.3)
75.0
(67.6 to 82.4)
76.9
(69.7 to 84.2)
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 51.9
Confidence Interval 95%
41.6 to 62.3
Estimation Comments Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.
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 54.0
Confidence Interval 95%
44.0 to 64.1
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
Hide 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 129 131 130
Mean (Standard Deviation)
Unit of Measure: μm
Baseline 687.0  (237.6) 679.9  (242.2) 688.7  (253.1)
Mean Absolute Change from Baseline at Month 6 -167.7  (308.4) -433.7  (295.9) -452.3  (257.6)
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 -272.2
Confidence Interval 95%
-329.9 to -214.5
Estimation Comments [Not Specified]
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 -283.8
Confidence Interval 95%
-337.8 to -229.8
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
Hide 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 127 130 128
Mean (Standard Deviation)
Unit of Measure: Points on the NEI VFQ-25 subscale
Baseline at Month 6 69.9  (22.6) 71.2  (22.2) 70.7  (20.3)
Change from baseline at Month 6 5.1  (17.1) 10.2  (17.4) 9.3  (18.1)
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 0.0019
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 5.8
Confidence Interval 95%
2.1 to 9.4
Estimation Comments [Not Specified]
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 0.0099
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 4.9
Confidence Interval 95%
1.2 to 8.6
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
Hide 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 127 130 128
Mean (Standard Deviation)
Unit of Measure: Points on the NEI VFQ-25 subscale
Baseline at Month 6 77.0  (22.5) 77.3  (19.8) 77.0  (19.7)
Change from baseline at Month 6 2.8  (15.6) 8.9  (13.7) 6.7  (16.3)
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 0.0002
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 6.3
Confidence Interval 95%
3.1 to 9.5
Estimation Comments [Not Specified]
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 0.0199
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 4.1
Confidence Interval 95%
0.7 to 7.6
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   --/--   --/--   --/-- 
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   13/129 (10.08%)   16/132 (12.12%)   13/129 (10.08%) 
Cardiac disorders       
Cardiomyopathy † 1  0/129 (0.00%)  1/132 (0.76%)  0/129 (0.00%) 
Arteriosclerosis Coronary Artery † 1  0/129 (0.00%)  0/132 (0.00%)  1/129 (0.78%) 
Coronary Artery Disease † 1  2/129 (1.55%)  1/132 (0.76%)  1/129 (0.78%) 
Cardiac Failure Congestive † 1  0/129 (0.00%)  1/132 (0.76%)  0/129 (0.00%) 
Acute Coronary Syndrome † 1  1/129 (0.78%)  0/132 (0.00%)  0/129 (0.00%) 
Angina Pectoris † 1  0/129 (0.00%)  0/132 (0.00%)  1/129 (0.78%) 
Myocardial Infarction † 1  0/129 (0.00%)  1/132 (0.76%)  1/129 (0.78%) 
Atrial Fibrillation † 1  0/129 (0.00%)  0/132 (0.00%)  1/129 (0.78%) 
Supraventricular Tachycardia † 1  1/129 (0.78%)  0/132 (0.00%)  0/129 (0.00%) 
Endocrine disorders       
Inappropriate Antidiuretic Hormone Secretion † 1  0/129 (0.00%)  1/132 (0.76%)  0/129 (0.00%) 
Eye disorders       
Blindness Unilateral † 1  0/129 (0.00%)  0/132 (0.00%)  1/129 (0.78%) 
Vitreous Hemorrhage † 1  1/129 (0.78%)  0/132 (0.00%)  0/129 (0.00%) 
Corneal Edema † 1  0/129 (0.00%)  1/132 (0.76%)  0/129 (0.00%) 
Iris Neovascularization † 1  0/129 (0.00%)  0/132 (0.00%)  1/129 (0.78%) 
Retinal Disorder † 1  0/129 (0.00%)  1/132 (0.76%)  0/129 (0.00%) 
Macular Ischemia † 1  1/129 (0.78%)  0/132 (0.00%)  0/129 (0.00%) 
Retinal Artery Occlusion † 1  0/129 (0.00%)  1/132 (0.76%)  0/129 (0.00%) 
Retinal Vascular Disorder † 1  0/129 (0.00%)  1/132 (0.76%)  0/129 (0.00%) 
Retinal Vascular Occlusion † 1  0/129 (0.00%)  0/132 (0.00%)  1/129 (0.78%) 
Retinal Vein Occlusion † 1  2/129 (1.55%)  1/132 (0.76%)  1/129 (0.78%) 
Maculopathy † 1  0/129 (0.00%)  1/132 (0.76%)  0/129 (0.00%) 
Retinal Depigmentation † 1  0/129 (0.00%)  1/132 (0.76%)  0/129 (0.00%) 
Macular Edema † 1  2/129 (1.55%)  2/132 (1.52%)  0/129 (0.00%) 
Gastrointestinal disorders       
Colitis † 1  0/129 (0.00%)  1/132 (0.76%)  1/129 (0.78%) 
Umbilical Hernia † 1  0/129 (0.00%)  1/132 (0.76%)  0/129 (0.00%) 
General disorders       
Chest Pain † 1  0/129 (0.00%)  1/132 (0.76%)  0/129 (0.00%) 
Immune system disorders       
Food Allergy † 1  0/129 (0.00%)  0/132 (0.00%)  1/129 (0.78%) 
Infections and infestations       
Diverticulitis † 1  1/129 (0.78%)  0/132 (0.00%)  1/129 (0.78%) 
Cellulitis † 1  0/129 (0.00%)  1/132 (0.76%)  0/129 (0.00%) 
Bronchitis † 1  0/129 (0.00%)  1/132 (0.76%)  0/129 (0.00%) 
Injury, poisoning and procedural complications       
Lead Dislodgement † 1  0/129 (0.00%)  0/132 (0.00%)  1/129 (0.78%) 
Hip Fracture † 1  1/129 (0.78%)  0/132 (0.00%)  0/129 (0.00%) 
Humerus Fracture † 1  0/129 (0.00%)  0/132 (0.00%)  1/129 (0.78%) 
Metabolism and nutrition disorders       
Hyponatremia † 1  0/129 (0.00%)  1/132 (0.76%)  0/129 (0.00%) 
Musculoskeletal and connective tissue disorders       
Spinal Osteoarthritis † 1  0/129 (0.00%)  0/132 (0.00%)  1/129 (0.78%) 
Lumbar Spinal Stenosis † 1  0/129 (0.00%)  0/132 (0.00%)  1/129 (0.78%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colon Cancer † 1  1/129 (0.78%)  0/132 (0.00%)  0/129 (0.00%) 
Gastric Cancer † 1  1/129 (0.78%)  0/132 (0.00%)  0/129 (0.00%) 
Uterine Leiomyoma † 1  0/129 (0.00%)  0/132 (0.00%)  1/129 (0.78%) 
Nervous system disorders       
Syncope † 1  0/129 (0.00%)  2/132 (1.52%)  0/129 (0.00%) 
Transient Ischemic Attack † 1  0/129 (0.00%)  0/132 (0.00%)  1/129 (0.78%) 
Renal and urinary disorders       
Urinary Retention † 1  0/129 (0.00%)  1/132 (0.76%)  0/129 (0.00%) 
Renal Failure Acute † 1  0/129 (0.00%)  1/132 (0.76%)  0/129 (0.00%) 
Vascular disorders       
Venous Occlusion † 1  1/129 (0.78%)  0/132 (0.00%)  0/129 (0.00%) 
Deep Vein Thrombosis † 1  0/129 (0.00%)  1/132 (0.76%)  0/129 (0.00%) 
Hypertension † 1  1/129 (0.78%)  0/132 (0.00%)  0/129 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
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   116/129 (89.92%)   113/132 (85.61%)   111/129 (86.05%) 
Eye disorders       
Conjunctival Hemorrhage † 1  43/129 (33.33%)  57/132 (43.18%)  53/129 (41.09%) 
Eye Irritation † 1  6/129 (4.65%)  6/132 (4.55%)  10/129 (7.75%) 
Eye Pain † 1  14/129 (10.85%)  12/132 (9.09%)  24/129 (18.60%) 
Foreign Body Sensation in Eyes † 1  5/129 (3.88%)  4/132 (3.03%)  9/129 (6.98%) 
Iris Neovascularization † 1  9/129 (6.98%)  2/132 (1.52%)  1/129 (0.78%) 
Macular Edema † 1  11/129 (8.53%)  7/132 (5.30%)  4/129 (3.10%) 
Maculopathy † 1  13/129 (10.08%)  21/132 (15.91%)  19/129 (14.73%) 
Myodesopsia † 1  5/129 (3.88%)  9/132 (6.82%)  12/129 (9.30%) 
Ocular Vascular Disorder † 1  0/129 (0.00%)  2/132 (1.52%)  8/129 (6.20%) 
Optic Disc Vascular Disorder † 1  8/129 (6.20%)  7/132 (5.30%)  2/129 (1.55%) 
Retinal Depigmentation † 1  8/129 (6.20%)  12/132 (9.09%)  10/129 (7.75%) 
Retinal Exudates † 1  18/129 (13.95%)  36/132 (27.27%)  25/129 (19.38%) 
Retinal Hemorrhage † 1  17/129 (13.18%)  15/132 (11.36%)  16/129 (12.40%) 
Retinal Pigmentation † 1  4/129 (3.10%)  7/132 (5.30%)  2/129 (1.55%) 
Retinal Vascular Disorder † 1  19/129 (14.73%)  21/132 (15.91%)  19/129 (14.73%) 
Vitreous Detachment † 1  6/129 (4.65%)  1/132 (0.76%)  8/129 (6.20%) 
Vitreous Hemorrhage † 1  8/129 (6.20%)  5/132 (3.79%)  7/129 (5.43%) 
Infections and infestations       
Nasopharyngitis † 1  3/129 (2.33%)  8/132 (6.06%)  7/129 (5.43%) 
Investigations       
Intraocular Pressure Increased † 1  5/129 (3.88%)  11/132 (8.33%)  11/129 (8.53%) 
Vascular disorders       
Hypertension † 1  8/129 (6.20%)  4/132 (3.03%)  3/129 (2.33%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Genentech, Inc.
Phone: 800-821-8590
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00485836    
Other Study ID Numbers: FVF4166g
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: July 28, 2017