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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)

This study has been completed.
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00485836
First received: June 11, 2007
Last updated: February 1, 2011
Last verified: February 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: Sham injection
Drug: Ranibizumab injection 0.3 mg
Drug: Ranibizumab injection 0.5 mg

  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   130   132   130 
Received Study Drug (Safety Population)   129   132   129 
COMPLETED   115   129   119 
NOT COMPLETED   15   3   11 



  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]
 130   132   130   392 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.4  (13.1)   69.7  (11.6)   67.6  (12.4)   67.6  (12.5) 
Age, Customized 
[Units: 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 
Gender 
[Units: Participants]
       
Female   58   61   50   169 
Male   72   71   80   223 


  Outcome Measures
  Hide 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 ]

Measure Type Primary
Measure Title Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months
Measure 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  
Safety Issue No  

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.
Intent to treat (randomized) population. Missing values were imputed using the last-observation-carried-forward (LOCF) method.

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.

Measured Values
   Sham Injection   Ranibizumab Injection 0.3 mg   Ranibizumab Injection 0.5 mg 
Participants Analyzed 
[Units: Participants]
 130   132   130 
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months 
[Units: Units on a scale]
Mean (Standard Deviation)
     
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) 


Statistical Analysis 1 for Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months
Groups [1] Sham Injection vs. Ranibizumab Injection 0.3 mg
Method [2] ANOVA
P Value [3] <0.0001
Difference in Least Squares means [4] 11.5
95% Confidence Interval 7.7 to 15.3
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months
Groups [1] Sham Injection vs. Ranibizumab Injection 0.5 mg
Method [2] ANOVA
P Value [3] <0.0001
Difference in Least Squares means [4] 13.8
95% Confidence Interval 10.3 to 17.4
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.
[4] Other relevant estimation information:
  No text entered.



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

Measure Type Secondary
Measure Title Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With Baseline
Measure 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  
Safety Issue No  

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.
Intent to treat (randomized) population. Missing values were imputed using the LOCF method.

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.

Measured Values
   Sham Injection   Ranibizumab Injection 0.3 mg   Ranibizumab Injection 0.5 mg 
Participants Analyzed 
[Units: Participants]
 130   132   130 
Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With Baseline 
[Units: Percentage of participants]
Number (95% Confidence Interval)
 16.9 
 (10.5 to 23.4) 
 46.2 
 (37.7 to 54.7) 
 47.7 
 (39.1 to 56.3) 


Statistical Analysis 1 for Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With Baseline
Groups [1] Sham Injection vs. Ranibizumab Injection 0.3 mg
Method [2] Cochran-Mantel-Haenszel χ²
P Value [3] <0.0001
Difference in percentage [4] 29.3
95% Confidence Interval 18.8 to 39.7
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.

Statistical Analysis 2 for Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With Baseline
Groups [1] Sham Injection vs. Ranibizumab Injection 0.5 mg
Method [2] Cochran-Mantel-Haenszel χ²
P Value [3] <0.0001
Difference in percentage [4] 30.3
95% Confidence Interval 19.6 to 40.9
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.



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

Measure Type Secondary
Measure Title Percentage of Participants Who Lost < 15 Letters in BCVA Score at Month 6 Compared With Baseline
Measure 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  
Safety Issue No  

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.
Intent to treat (randomized) population. Missing values were imputed using the LOCF method.

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.

Measured Values
   Sham Injection   Ranibizumab Injection 0.3 mg   Ranibizumab Injection 0.5 mg 
Participants Analyzed 
[Units: Participants]
 130   132   130 
Percentage of Participants Who Lost < 15 Letters in BCVA Score at Month 6 Compared With Baseline 
[Units: Percentage of participants]
Number (95% Confidence Interval)
 84.6 
 (78.4 to 90.8) 
 96.2 
 (93.0 to 99.5) 
 98.5 
 (96.3 to 100) 


Statistical Analysis 1 for Percentage of Participants Who Lost < 15 Letters in BCVA Score at Month 6 Compared With Baseline
Groups [1] Sham Injection vs. Ranibizumab Injection 0.3 mg
Method [2] Cochran−Mantel−Haenszel χ²
P Value [3] 0.0019
Difference in percentage [4] 11.3
95% Confidence Interval 4.3 to 18.2
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.

Statistical Analysis 2 for Percentage of Participants Who Lost < 15 Letters in BCVA Score at Month 6 Compared With Baseline
Groups [1] Sham Injection vs. Ranibizumab Injection 0.5 mg
Method [2] Cochran−Mantel−Haenszel χ²
P Value [3] <0.0001
Difference in percentage [4] 13.6
95% Confidence Interval 7.2 to 20.1
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.



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

Measure Type Secondary
Measure Title Percentage of Participants With a Central Foveal Thickness of ≤ 250 μm at Month 6
Measure 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  
Safety Issue No  

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.
Intent to treat (randomized) population. Missing values were imputed using the LOCF method.

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.

Measured Values
   Sham Injection   Ranibizumab Injection 0.3 mg   Ranibizumab Injection 0.5 mg 
Participants Analyzed 
[Units: Participants]
 130   132   130 
Percentage of Participants With a Central Foveal Thickness of ≤ 250 μm at Month 6 
[Units: Percentage of participants]
Number (95% Confidence Interval)
 23.1 
 (15.8 to 30.3) 
 75.0 
 (67.6 to 82.4) 
 76.9 
 (69.7 to 84.2) 


Statistical Analysis 1 for Percentage of Participants With a Central Foveal Thickness of ≤ 250 μm at Month 6
Groups [1] Sham Injection vs. Ranibizumab Injection 0.3 mg
Method [2] Cochran-Mantel-Haenszel χ²
P Value [3] <0.0001
Difference in percentage [4] 51.9
95% Confidence Interval 41.6 to 62.3
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.

Statistical Analysis 2 for Percentage of Participants With a Central Foveal Thickness of ≤ 250 μm at Month 6
Groups [1] Sham Injection vs. Ranibizumab Injection 0.5 mg
Method [2] Cochran-Mantel-Haenszel χ²
P Value [3] <0.0001
Difference in percentage [4] 54.0
95% Confidence Interval 44.0 to 64.1
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.



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

Measure Type Secondary
Measure Title Mean Absolute Change From Baseline in Central Foveal Thickness at Month 6
Measure 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  
Safety Issue No  

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.
Intent to treat (randomized) population. Missing values were imputed using the LOCF method.

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.

Measured Values
   Sham Injection   Ranibizumab Injection 0.3 mg   Ranibizumab Injection 0.5 mg 
Participants Analyzed 
[Units: Participants]
 129   131   130 
Mean Absolute Change From Baseline in Central Foveal Thickness at Month 6 
[Units: μm]
Mean (Standard Deviation)
     
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) 


Statistical Analysis 1 for Mean Absolute Change From Baseline in Central Foveal Thickness at Month 6
Groups [1] Sham Injection vs. Ranibizumab Injection 0.3 mg
Method [2] ANCOVA
P Value [3] <0.0001
Difference in Least Squares means [4] -272.2
95% Confidence Interval -329.9 to -214.5
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Mean Absolute Change From Baseline in Central Foveal Thickness at Month 6
Groups [1] Sham Injection vs. Ranibizumab Injection 0.5 mg
Method [2] ANCOVA
P Value [3] <0.0001
Difference in Least Squares means [4] -283.8
95% Confidence Interval -337.8 to -229.8
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Near Activities Subscale Score at Month 6
Measure 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  
Safety Issue No  

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.
Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.

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.

Measured Values
   Sham Injection   Ranibizumab Injection 0.3 mg   Ranibizumab Injection 0.5 mg 
Participants Analyzed 
[Units: Participants]
 127   130   128 
Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Near Activities Subscale Score at Month 6 
[Units: Points on the NEI VFQ-25 subscale]
Mean (Standard Deviation)
     
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) 


Statistical Analysis 1 for Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Near Activities Subscale Score at Month 6
Groups [1] Sham Injection vs. Ranibizumab Injection 0.3 mg
Method [2] ANCOVA
P Value [3] 0.0019
Difference in Least Squares means [4] 5.8
95% Confidence Interval 2.1 to 9.4
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Near Activities Subscale Score at Month 6
Groups [1] Sham Injection vs. Ranibizumab Injection 0.5 mg
Method [2] ANCOVA
P Value [3] 0.0099
Difference in Least Squares means [4] 4.9
95% Confidence Interval 1.2 to 8.6
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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

Measure Type Secondary
Measure Title Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6
Measure 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  
Safety Issue No  

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.
Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.

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.

Measured Values
   Sham Injection   Ranibizumab Injection 0.3 mg   Ranibizumab Injection 0.5 mg 
Participants Analyzed 
[Units: Participants]
 127   130   128 
Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6 
[Units: Points on the NEI VFQ-25 subscale]
Mean (Standard Deviation)
     
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) 


Statistical Analysis 1 for Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6
Groups [1] Sham Injection vs. Ranibizumab Injection 0.3 mg
Method [2] ANCOVA
P Value [3] 0.0002
Difference in Least Squares means [4] 6.3
95% Confidence Interval 3.1 to 9.5
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6
Groups [1] Sham Injection vs. Ranibizumab Injection 0.5 mg
Method [2] ANCOVA
P Value [3] 0.0199
Difference in Least Squares means [4] 4.1
95% Confidence Interval 0.7 to 7.6
[1] Additional details about the analysis, such as null hypothesis and power calculation:
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[2] Other relevant method information, such as adjustments or degrees of freedom:
  Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4] Other relevant estimation information:
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  Serious Adverse Events


  Other Adverse Events


  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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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Genentech, Inc.
phone: 800-821-8590


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Disclosures Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00485836     History of Changes
Other Study ID Numbers: FVF4166g
Study First Received: June 11, 2007
Results First Received: August 16, 2010
Last Updated: February 1, 2011
Health Authority: United States: Food and Drug Administration