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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
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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.

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.

Serious Adverse Events
    Sham Injection   Ranibizumab Injection 0.3 mg   Ranibizumab Injection 0.5 mg
Total, serious adverse events       
# participants affected / at risk   13/129 (10.08%)   16/132 (12.12%)   13/129 (10.08%) 
Cardiac disorders       
Cardiomyopathy † 1       
# participants affected / at risk   0/129 (0.00%)   1/132 (0.76%)   0/129 (0.00%) 
Arteriosclerosis Coronary Artery † 1       
# participants affected / at risk   0/129 (0.00%)   0/132 (0.00%)   1/129 (0.78%) 
Coronary Artery Disease † 1       
# participants affected / at risk   2/129 (1.55%)   1/132 (0.76%)   1/129 (0.78%) 
Cardiac Failure Congestive † 1       
# participants affected / at risk   0/129 (0.00%)   1/132 (0.76%)   0/129 (0.00%) 
Acute Coronary Syndrome † 1       
# participants affected / at risk   1/129 (0.78%)   0/132 (0.00%)   0/129 (0.00%) 
Angina Pectoris † 1       
# participants affected / at risk   0/129 (0.00%)   0/132 (0.00%)   1/129 (0.78%) 
Myocardial Infarction † 1       
# participants affected / at risk   0/129 (0.00%)   1/132 (0.76%)   1/129 (0.78%) 
Atrial Fibrillation † 1       
# participants affected / at risk   0/129 (0.00%)   0/132 (0.00%)   1/129 (0.78%) 
Supraventricular Tachycardia † 1       
# participants affected / at risk   1/129 (0.78%)   0/132 (0.00%)   0/129 (0.00%) 
Endocrine disorders       
Inappropriate Antidiuretic Hormone Secretion † 1       
# participants affected / at risk   0/129 (0.00%)   1/132 (0.76%)   0/129 (0.00%) 
Eye disorders       
Blindness Unilateral † 1       
# participants affected / at risk   0/129 (0.00%)   0/132 (0.00%)   1/129 (0.78%) 
Vitreous Hemorrhage † 1       
# participants affected / at risk   1/129 (0.78%)   0/132 (0.00%)   0/129 (0.00%) 
Corneal Edema † 1       
# participants affected / at risk   0/129 (0.00%)   1/132 (0.76%)   0/129 (0.00%) 
Iris Neovascularization † 1       
# participants affected / at risk   0/129 (0.00%)   0/132 (0.00%)   1/129 (0.78%) 
Retinal Disorder † 1       
# participants affected / at risk   0/129 (0.00%)   1/132 (0.76%)   0/129 (0.00%) 
Macular Ischemia † 1       
# participants affected / at risk   1/129 (0.78%)   0/132 (0.00%)   0/129 (0.00%) 
Retinal Artery Occlusion † 1       
# participants affected / at risk   0/129 (0.00%)   1/132 (0.76%)   0/129 (0.00%) 
Retinal Vascular Disorder † 1       
# participants affected / at risk   0/129 (0.00%)   1/132 (0.76%)   0/129 (0.00%) 
Retinal Vascular Occlusion † 1       
# participants affected / at risk   0/129 (0.00%)   0/132 (0.00%)   1/129 (0.78%) 
Retinal Vein Occlusion † 1       
# participants affected / at risk   2/129 (1.55%)   1/132 (0.76%)   1/129 (0.78%) 
Maculopathy † 1       
# participants affected / at risk   0/129 (0.00%)   1/132 (0.76%)   0/129 (0.00%) 
Retinal Depigmentation † 1       
# participants affected / at risk   0/129 (0.00%)   1/132 (0.76%)   0/129 (0.00%) 
Macular Edema † 1       
# participants affected / at risk   2/129 (1.55%)   2/132 (1.52%)   0/129 (0.00%) 
Gastrointestinal disorders       
Colitis † 1       
# participants affected / at risk   0/129 (0.00%)   1/132 (0.76%)   1/129 (0.78%) 
Umbilical Hernia † 1       
# participants affected / at risk   0/129 (0.00%)   1/132 (0.76%)   0/129 (0.00%) 
General disorders       
Chest Pain † 1       
# participants affected / at risk   0/129 (0.00%)   1/132 (0.76%)   0/129 (0.00%) 
Immune system disorders       
Food Allergy † 1       
# participants affected / at risk   0/129 (0.00%)   0/132 (0.00%)   1/129 (0.78%) 
Infections and infestations       
Diverticulitis † 1       
# participants affected / at risk   1/129 (0.78%)   0/132 (0.00%)   1/129 (0.78%) 
Cellulitis † 1       
# participants affected / at risk   0/129 (0.00%)   1/132 (0.76%)   0/129 (0.00%) 
Bronchitis † 1       
# participants affected / at risk   0/129 (0.00%)   1/132 (0.76%)   0/129 (0.00%) 
Injury, poisoning and procedural complications       
Lead Dislodgement † 1       
# participants affected / at risk   0/129 (0.00%)   0/132 (0.00%)   1/129 (0.78%) 
Hip Fracture † 1       
# participants affected / at risk   1/129 (0.78%)   0/132 (0.00%)   0/129 (0.00%) 
Humerus Fracture † 1       
# participants affected / at risk   0/129 (0.00%)   0/132 (0.00%)   1/129 (0.78%) 
Metabolism and nutrition disorders       
Hyponatremia † 1       
# participants affected / at risk   0/129 (0.00%)   1/132 (0.76%)   0/129 (0.00%) 
Musculoskeletal and connective tissue disorders       
Spinal Osteoarthritis † 1       
# participants affected / at risk   0/129 (0.00%)   0/132 (0.00%)   1/129 (0.78%) 
Lumbar Spinal Stenosis † 1       
# participants affected / at risk   0/129 (0.00%)   0/132 (0.00%)   1/129 (0.78%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colon Cancer † 1       
# participants affected / at risk   1/129 (0.78%)   0/132 (0.00%)   0/129 (0.00%) 
Gastric Cancer † 1       
# participants affected / at risk   1/129 (0.78%)   0/132 (0.00%)   0/129 (0.00%) 
Uterine Leiomyoma † 1       
# participants affected / at risk   0/129 (0.00%)   0/132 (0.00%)   1/129 (0.78%) 
Nervous system disorders       
Syncope † 1       
# participants affected / at risk   0/129 (0.00%)   2/132 (1.52%)   0/129 (0.00%) 
Transient Ischemic Attack † 1       
# participants affected / at risk   0/129 (0.00%)   0/132 (0.00%)   1/129 (0.78%) 
Renal and urinary disorders       
Urinary Retention † 1       
# participants affected / at risk   0/129 (0.00%)   1/132 (0.76%)   0/129 (0.00%) 
Renal Failure Acute † 1       
# participants affected / at risk   0/129 (0.00%)   1/132 (0.76%)   0/129 (0.00%) 
Vascular disorders       
Venous Occlusion † 1       
# participants affected / at risk   1/129 (0.78%)   0/132 (0.00%)   0/129 (0.00%) 
Deep Vein Thrombosis † 1       
# participants affected / at risk   0/129 (0.00%)   1/132 (0.76%)   0/129 (0.00%) 
Hypertension † 1       
# participants affected / at risk   1/129 (0.78%)   0/132 (0.00%)   0/129 (0.00%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (12.0)




  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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  More Information