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


No publications provided by Genentech, Inc.

Publications automatically indexed to this study:

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