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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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Please note that although the table below is titled "Overall Study," the completion rates are for the 6-month Treatment Period only (i.e., does not include the 6-month Observation Period data).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sham Injection Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
Ranibizumab Injection 0.3 mg Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
Ranibizumab Injection 0.5 mg Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.

Participant Flow:   Overall Study
    Sham Injection   Ranibizumab Injection 0.3 mg   Ranibizumab Injection 0.5 mg
STARTED   130   132   130 
Received Study Drug (Safety Population)   129   132   129 
COMPLETED   115   129   119 
NOT COMPLETED   15   3   11 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Sham Injection Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
Ranibizumab Injection 0.3 mg Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
Ranibizumab Injection 0.5 mg Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
Total Total of all reporting groups

Baseline Measures
   Sham Injection   Ranibizumab Injection 0.3 mg   Ranibizumab Injection 0.5 mg   Total 
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
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1.  Primary:   Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months   [ Time Frame: Baseline and 6 months ]

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

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

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

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

6.  Secondary:   Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Near Activities Subscale Score at Month 6   [ Time Frame: Baseline and 6 months ]

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


  Serious Adverse Events


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

Frequency Threshold
Threshold above which other adverse events are reported   5  

Reporting Groups
  Description
Sham Injection Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
Ranibizumab Injection 0.3 mg Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
Ranibizumab Injection 0.5 mg Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.

Other Adverse Events
    Sham Injection   Ranibizumab Injection 0.3 mg   Ranibizumab Injection 0.5 mg
Total, other (not including serious) adverse events       
# participants affected / at risk   116/129 (89.92%)   113/132 (85.61%)   111/129 (86.05%) 
Eye disorders       
Conjunctival Hemorrhage † 1       
# participants affected / at risk   43/129 (33.33%)   57/132 (43.18%)   53/129 (41.09%) 
Eye Irritation † 1       
# participants affected / at risk   6/129 (4.65%)   6/132 (4.55%)   10/129 (7.75%) 
Eye Pain † 1       
# participants affected / at risk   14/129 (10.85%)   12/132 (9.09%)   24/129 (18.60%) 
Foreign Body Sensation in Eyes † 1       
# participants affected / at risk   5/129 (3.88%)   4/132 (3.03%)   9/129 (6.98%) 
Iris Neovascularization † 1       
# participants affected / at risk   9/129 (6.98%)   2/132 (1.52%)   1/129 (0.78%) 
Macular Edema † 1       
# participants affected / at risk   11/129 (8.53%)   7/132 (5.30%)   4/129 (3.10%) 
Maculopathy † 1       
# participants affected / at risk   13/129 (10.08%)   21/132 (15.91%)   19/129 (14.73%) 
Myodesopsia † 1       
# participants affected / at risk   5/129 (3.88%)   9/132 (6.82%)   12/129 (9.30%) 
Ocular Vascular Disorder † 1       
# participants affected / at risk   0/129 (0.00%)   2/132 (1.52%)   8/129 (6.20%) 
Optic Disc Vascular Disorder † 1       
# participants affected / at risk   8/129 (6.20%)   7/132 (5.30%)   2/129 (1.55%) 
Retinal Depigmentation † 1       
# participants affected / at risk   8/129 (6.20%)   12/132 (9.09%)   10/129 (7.75%) 
Retinal Exudates † 1       
# participants affected / at risk   18/129 (13.95%)   36/132 (27.27%)   25/129 (19.38%) 
Retinal Hemorrhage † 1       
# participants affected / at risk   17/129 (13.18%)   15/132 (11.36%)   16/129 (12.40%) 
Retinal Pigmentation † 1       
# participants affected / at risk   4/129 (3.10%)   7/132 (5.30%)   2/129 (1.55%) 
Retinal Vascular Disorder † 1       
# participants affected / at risk   19/129 (14.73%)   21/132 (15.91%)   19/129 (14.73%) 
Vitreous Detachment † 1       
# participants affected / at risk   6/129 (4.65%)   1/132 (0.76%)   8/129 (6.20%) 
Vitreous Hemorrhage † 1       
# participants affected / at risk   8/129 (6.20%)   5/132 (3.79%)   7/129 (5.43%) 
Infections and infestations       
Nasopharyngitis † 1       
# participants affected / at risk   3/129 (2.33%)   8/132 (6.06%)   7/129 (5.43%) 
Investigations       
Intraocular Pressure Increased † 1       
# participants affected / at risk   5/129 (3.88%)   11/132 (8.33%)   11/129 (8.53%) 
Vascular disorders       
Hypertension † 1       
# participants affected / at risk   8/129 (6.20%)   4/132 (3.03%)   3/129 (2.33%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (12.0)



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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