A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema (ME) With Center Involvement Secondary to Diabetes Mellitus (RIDE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00473382
First received: May 13, 2007
Last updated: August 1, 2013
Last verified: August 2013
Results First Received: November 30, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Diabetes Mellitus
Macular Edema
Interventions: Drug: Ranibizumab
Drug: Sham injection

  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
Patients were recruited from study sites in the United States, Argentina, Peru, Columbia, Chile, and Peru. There were 47 patients from the Latin American countries.

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
Ranibizumab 0.3 mg Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
Ranibizumab 0.5 mg Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
Sham Injection/Ranibizumab 0.5 mg Patients received a sham intravitreal injection monthly for 24 months. Patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months.

Participant Flow:   Overall Study
    Ranibizumab 0.3 mg     Ranibizumab 0.5 mg     Sham Injection/Ranibizumab 0.5 mg  
STARTED     125     127     130  
COMPLETED     98     98     102  
NOT COMPLETED     27     29     28  
Adverse Event                 1                 1                 3  
Death                 5                 10                 3  
Lost to Follow-up                 3                 3                 3  
Physician Decision                 2                 2                 1  
Subject non-compliance                 2                 1                 5  
Subject needed other treatment                 3                 2                 1  
Subject's decision                 11                 10                 12  



  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
Ranibizumab 0.3 mg Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months.
Ranibizumab 0.5 mg Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.
Sham Injection Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
Total Total of all reporting groups

Baseline Measures
    Ranibizumab 0.3 mg     Ranibizumab 0.5 mg     Sham Injection     Total  
Number of Participants  
[units: participants]
  125     127     130     382  
Age  
[units: years]
Mean ± Standard Deviation
  62.7  ± 11.1     61.8  ± 10.1     63.5  ± 10.8     62.7  ± 10.7  
Gender  
[units: participants]
       
Female     52     47     64     163  
Male     73     80     66     219  



  Outcome Measures
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1.  Primary:   Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24   [ Time Frame: Baseline to Month 24 ]

2.  Secondary:   Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24 and 36   [ Time Frame: Baseline to Months 24 and 36 ]

3.  Secondary:   Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Months 24 and 36   [ Time Frame: Months 24 and 36 ]

4.  Secondary:   Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 24 and 36   [ Time Frame: Baseline to Months 24 and 36 ]

5.  Secondary:   Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24 and 36 in Patients With Focal Edema at Baseline   [ Time Frame: Baseline to Months 24 and 36 ]

6.  Secondary:   Mean Change From Baseline in Central Foveal Thickness at Months 24 and 36   [ Time Frame: Baseline to Months 24 and 36 ]

7.  Secondary:   Percentage of Patients With a ≥ 3-step Worsening From Baseline in the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale Score for Eyes at Months 24 and 36   [ Time Frame: Baseline to Months 24 and 36 ]

8.  Secondary:   Percentage of Patients With Resolution of Leakage at Month 24   [ Time Frame: Baseline to Month 24 ]

9.  Secondary:   Mean Number of Macular Laser Treatments From Baseline Through Months 24 and 36   [ Time Frame: Baseline to Months 24 and 36 ]

10.  Secondary:   Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 36   [ Time Frame: Baseline to Month 36 ]


  Serious Adverse Events
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Time Frame Adverse events were recorded from the first day of treatment through Month 36.
Additional Description The sham Months 0-36 group includes patients randomized to sham; the majority crossed-over to ranibizumab 0.5 mg in Year 3. The sham Months 0-24 group includes patients who received sham during the first 24 months of the study. Serious adverse events that occurred after early crossover to ranibizumab (defined as prior to Month 25) are not included.

Reporting Groups
  Description
Ranibizumab 0.3 mg - Months 0-36 Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
Ranibizumab 0.5 mg - Months 0-36 Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
Sham Injection/Ranibizumab 0.5 mg - Months 0-36 Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Data in this column represent the safety data in the sham group during the entire 36 months of the trial; most patients crossed over to receive ranibizumab 0.5 mg monthly in the third year.
Sham Injection - Months 0-24 Patients received a sham intravitreal injection monthly for 24 months. Data in this column represent the safety data in the sham group during the first 24 months of the trial when patients were receiving only sham injections. Safety data shown here are also included in the Sham/Ranibizumab 0.5 mg - Months 0-36 column.

Serious Adverse Events
    Ranibizumab 0.3 mg - Months 0-36     Ranibizumab 0.5 mg - Months 0-36     Sham Injection/Ranibizumab 0.5 mg - Months 0-36     Sham Injection - Months 0-24  
Total, serious adverse events          
# participants affected / at risk     54/125 (43.20%)     67/124 (54.03%)     68/127 (53.54%)     54/127 (42.52%)  
Blood and lymphatic system disorders          
Anaemia † 1        
# participants affected / at risk     2/125 (1.60%)     1/124 (0.81%)     1/127 (0.79%)     1/127 (0.79%)  
Febrile neutropenia † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Thrombocytopenia † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Cardiac disorders          
Acute myocardial infarction † 1        
# participants affected / at risk     4/125 (3.20%)     1/124 (0.81%)     2/127 (1.57%)     0/127 (0.00%)  
Angina pectoris † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     0/127 (0.00%)  
Angina unstable † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     3/127 (2.36%)     2/127 (1.57%)  
Arrhythmia † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     1/127 (0.79%)     1/127 (0.79%)  
Arteriosclerosis coronary artery † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     0/127 (0.00%)  
Atrial fibrillation † 1        
# participants affected / at risk     3/125 (2.40%)     1/124 (0.81%)     2/127 (1.57%)     1/127 (0.79%)  
Atrioventricular block complete † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Atrioventricular block second degree † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Bradycardia † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Cardiac arrest † 1        
# participants affected / at risk     1/125 (0.80%)     3/124 (2.42%)     0/127 (0.00%)     0/127 (0.00%)  
Cardiac failure acute † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Cardiac failure congestive † 1        
# participants affected / at risk     3/125 (2.40%)     4/124 (3.23%)     7/127 (5.51%)     6/127 (4.72%)  
Cardio-respiratory arrest † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     1/127 (0.79%)     0/127 (0.00%)  
Cardiogenic shock † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Coronary artery disease † 1        
# participants affected / at risk     2/125 (1.60%)     6/124 (4.84%)     3/127 (2.36%)     1/127 (0.79%)  
Coronary artery occlusion † 1        
# participants affected / at risk     1/125 (0.80%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Intracardiac thrombus † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Left ventricular dysfunction † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Myocardial infarction † 1        
# participants affected / at risk     8/125 (6.40%)     3/124 (2.42%)     7/127 (5.51%)     6/127 (4.72%)  
Sick sinus syndrome † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     0/127 (0.00%)  
Sinus bradycardia † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     0/127 (0.00%)  
Ventricular fibrillation † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Ventricular tachycardia † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Ear and labyrinth disorders          
Deafness † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Endocrine disorders          
Basedow's disease † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Goitre † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Hypothyroidism † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Eye disorders          
Angle closure glaucoma (S) † 1 [3]        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Blindness unilateral (F) † 1 [4]        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Cataract (S) † 1 [3]        
# participants affected / at risk     1/125 (0.80%)     3/124 (2.42%)     0/127 (0.00%)     0/127 (0.00%)  
Choroidal neovascularisation (S) † 1 [3]        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Corneal opacity (S) † 1 [3]        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Diabetic retinal oedema (S) † 1 [3]        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Glaucoma (F) † 1 [4]        
# participants affected / at risk     0/125 (0.00%)     2/124 (1.61%)     0/127 (0.00%)     0/127 (0.00%)  
Macular ischaemia (F) † 1 [4]        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     1/127 (0.79%)     1/127 (0.79%)  
Macular oedema (F) † 1 [4]        
# participants affected / at risk     1/125 (0.80%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Macular oedema (S) † 1 [3]        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Papilloedema (F) † 1 [4]        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Retinal detachment (F) † 1 [4]        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Retinal detachment (S) † 1 [3]        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Retinal haemorrhage (S) † 1 [3]        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Visual acuity reduced (F) † 1 [4]        
# participants affected / at risk     2/125 (1.60%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Visual acuity reduced (S) † 1 [3]        
# participants affected / at risk     0/125 (0.00%)     2/124 (1.61%)     2/127 (1.57%)     2/127 (1.57%)  
Vitreous haemorrhage (F) † 1 [4]        
# participants affected / at risk     10/125 (8.00%)     4/124 (3.23%)     3/127 (2.36%)     2/127 (1.57%)  
Vitreous haemorrhage (S) † 1 [3]        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     4/127 (3.15%)     3/127 (2.36%)  
Gastrointestinal disorders          
Abdominal pain † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Appendiceal mucocoele † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Colonic polyp † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Diarrhoea † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Dysphagia † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Gastric haemorrhage † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Gastritis † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     0/127 (0.00%)  
Gastrointestinal haemorrhage † 1        
# participants affected / at risk     1/125 (0.80%)     1/124 (0.81%)     2/127 (1.57%)     2/127 (1.57%)  
Ileus † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Pancreatitis † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     1/127 (0.79%)     0/127 (0.00%)  
Pancreatitis acute † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Peptic ulcer haemorrhage † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
General disorders          
Chest pain † 1        
# participants affected / at risk     1/125 (0.80%)     1/124 (0.81%)     1/127 (0.79%)     2/127 (1.57%)  
Non-cardiac chest pain † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     1/127 (0.79%)     0/127 (0.00%)  
Oedema peripheral † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Hepatobiliary disorders          
Bile duct obstruction † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Cholecystitis † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Cholecystitis acute † 1        
# participants affected / at risk     1/125 (0.80%)     1/124 (0.81%)     2/127 (1.57%)     1/127 (0.79%)  
Cholelithiasis † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Infections and infestations          
Abscess † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Arthritis infective † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Bacteraemia † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Bone abscess † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Bronchitis † 1        
# participants affected / at risk     1/125 (0.80%)     1/124 (0.81%)     1/127 (0.79%)     1/127 (0.79%)  
Cellulitis † 1        
# participants affected / at risk     3/125 (2.40%)     2/124 (1.61%)     3/127 (2.36%)     3/127 (2.36%)  
Device related sepsis † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Diverticulitis † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     1/127 (0.79%)     1/127 (0.79%)  
Empyema † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Endophthalmitis (F) † 1 [4]        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Endophthalmitis (S) † 1 [3]        
# participants affected / at risk     3/125 (2.40%)     2/124 (1.61%)     0/127 (0.00%)     0/127 (0.00%)  
Escherichia sepsis † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Gangrene † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     1/127 (0.79%)     0/127 (0.00%)  
Gastroenteritis † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Gastroenteritis viral † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Infected skin ulcer † 1        
# participants affected / at risk     0/125 (0.00%)     3/124 (2.42%)     0/127 (0.00%)     0/127 (0.00%)  
Infection † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Infectious peritonitis † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Kidney infection † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Localised infection † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     2/127 (1.57%)     1/127 (0.79%)  
Osteomyelitis † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Osteomyelitis chronic † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Pneumonia † 1        
# participants affected / at risk     1/125 (0.80%)     8/124 (6.45%)     5/127 (3.94%)     4/127 (3.15%)  
Pneumonia mycoplasmal † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Pseudomonal sepsis † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Pyelonephritis acute † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Sepsis † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Sepsis syndrome † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Urinary tract infection † 1        
# participants affected / at risk     2/125 (1.60%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Wound infection † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Injury, poisoning and procedural complications          
Ankle fracture † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Carbon monoxide poisoning † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Cataract traumatic (S) † 1 [3]        
# participants affected / at risk     1/125 (0.80%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Corneal abrasion (S) † 1 [3]        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     1/127 (0.79%)     0/127 (0.00%)  
Craniocerebral injury † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     0/127 (0.00%)  
Drug administration error † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Expired drug administered † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Fall † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     1/127 (0.79%)     1/127 (0.79%)  
Foot fracture † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Head injury † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Hip fracture † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     2/127 (1.57%)     1/127 (0.79%)  
Medication error (S) † 1 [3]        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Post procedural complication (S) † 1 [3]        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     0/127 (0.00%)  
Postoperative ileus † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     0/127 (0.00%)  
Procedural complication (S) † 1 [3]        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     0/127 (0.00%)  
Road traffic accident † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Subdural haematoma † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     0/127 (0.00%)  
Tendon rupture † 1        
# participants affected / at risk     1/125 (0.80%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Traumatic brain injury † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     0/127 (0.00%)     1/127 (0.79%)  
Upper limb fracture † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Investigations          
Blood creatinine increased † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Hepatic enzyme increased † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Intraocular pressure increased (S) † 1 [3]        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Metabolism and nutrition disorders          
Dehydration † 1        
# participants affected / at risk     2/125 (1.60%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Diabetes mellitus † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     1/127 (0.79%)     1/127 (0.79%)  
Diabetic foot † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Diabetic ketoacidosis † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Hyperglycaemia † 1        
# participants affected / at risk     0/125 (0.00%)     2/124 (1.61%)     0/127 (0.00%)     0/127 (0.00%)  
Hyperkalaemia † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     1/127 (0.79%)     1/127 (0.79%)  
Hypoglycaemia † 1        
# participants affected / at risk     1/125 (0.80%)     1/124 (0.81%)     2/127 (1.57%)     2/127 (1.57%)  
Lactic acidosis † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Musculoskeletal and connective tissue disorders          
Arthralgia † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     1/127 (0.79%)     0/127 (0.00%)  
Bursitis † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Groin pain † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     0/127 (0.00%)  
Intervertebral disc protrusion † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Monarthritis † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Osteoarthritis † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Polymyalgia rheumatica † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Rhabdomyolysis † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     2/127 (1.57%)     2/127 (1.57%)  
Rotator cuff syndrome † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Spinal column stenosis † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     1/127 (0.79%)     0/127 (0.00%)  
Spondylolisthesis † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)          
Acute leukaemia † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Bladder neoplasm † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Bladder papilloma † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     0/127 (0.00%)  
Breast cancer † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Colon cancer † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Hepatic neoplasm malignant † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Metastatic neoplasm † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Non−hodgkin’s lymphoma † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Ovarian cancer † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Pancreatic carcinoma metastatic † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Pituitary tumour benign † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Prostate cancer † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Renal cancer † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     0/127 (0.00%)  
Squamous cell carcinoma † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Tongue neoplasm malignant stage unspecified † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Nervous system disorders          
Carotid artery occlusion † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Carotid artery stenosis † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Cerebral haemorrhage † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Cerebral infarction † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Cerebrovascular accident † 1        
# participants affected / at risk     3/125 (2.40%)     4/124 (3.23%)     2/127 (1.57%)     2/127 (1.57%)  
Convulsion † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Dizziness † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Dyskinesia † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Encephalopathy † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Hemiplegia † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Hydrocephalus † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Lumbar radiculopathy † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Parkinson’s disease † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Presyncope † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     1/127 (0.79%)     1/127 (0.79%)  
Syncope † 1        
# participants affected / at risk     2/125 (1.60%)     1/124 (0.81%)     1/127 (0.79%)     1/127 (0.79%)  
Transient ischaemic attack † 1        
# participants affected / at risk     1/125 (0.80%)     1/124 (0.81%)     3/127 (2.36%)     2/127 (1.57%)  
VIIth nerve paralysis † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Psychiatric disorders          
Confusional state † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Major depression † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Schizophrenia † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Suicidal ideation † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Renal and urinary disorders          
Diabetic nephropathy † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Nephrolithiasis † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Renal failure † 1        
# participants affected / at risk     3/125 (2.40%)     4/124 (3.23%)     4/127 (3.15%)     3/127 (2.36%)  
Renal failure acute † 1        
# participants affected / at risk     2/125 (1.60%)     1/124 (0.81%)     2/127 (1.57%)     2/127 (1.57%)  
Renal failure chronic † 1        
# participants affected / at risk     2/125 (1.60%)     3/124 (2.42%)     2/127 (1.57%)     0/127 (0.00%)  
Urinary tract obstruction † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Reproductive system and breast disorders          
Benign prostatic hyperplasia † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     1/127 (0.79%)     0/127 (0.00%)  
Respiratory, thoracic and mediastinal disorders          
Chronic obstructive pulmonary disease † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     1/127 (0.79%)     1/127 (0.79%)  
Dyspnoea † 1        
# participants affected / at risk     1/125 (0.80%)     2/124 (1.61%)     0/127 (0.00%)     0/127 (0.00%)  
Pulmonary hypertension † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Pulmonary oedema † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Respiratory distress † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Respiratory failure † 1        
# participants affected / at risk     1/125 (0.80%)     1/124 (0.81%)     1/127 (0.79%)     0/127 (0.00%)  
Respiratory tract congestion † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Skin and subcutaneous tissue disorders          
Angioedema † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Skin ulcer † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Surgical and medical procedures          
Hospitalisation † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Nephroureterectomy † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     0/127 (0.00%)  
Vascular disorders          
Aortic aneurysm † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Aortic aneurysm rupture † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Aortic stenosis † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     0/127 (0.00%)  
Deep vein thrombosis † 1        
# participants affected / at risk     2/125 (1.60%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Femoral artery occlusion † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Hypertension † 1        
# participants affected / at risk     2/125 (1.60%)     3/124 (2.42%)     0/127 (0.00%)     0/127 (0.00%)  
Hypertensive crisis † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Hypotension † 1        
# participants affected / at risk     1/125 (0.80%)     0/124 (0.00%)     0/127 (0.00%)     0/127 (0.00%)  
Orthostatic hypotension † 1        
# participants affected / at risk     0/125 (0.00%)     1/124 (0.81%)     0/127 (0.00%)     0/127 (0.00%)  
Peripheral arterial occlusive disease † 1        
# participants affected / at risk     0/125 (0.00%)     2/124 (1.61%)     0/127 (0.00%)     0/127 (0.00%)  
Thrombosis † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     1/127 (0.79%)  
Vascular insufficiency † 1        
# participants affected / at risk     0/125 (0.00%)     0/124 (0.00%)     1/127 (0.79%)     0/127 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (13.1)
[3] (S)=study eye
[4] (F)=fellow eye




  Other Adverse Events


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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


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Publications automatically indexed to this study:

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00473382     History of Changes
Other Study ID Numbers: FVF4168g
Study First Received: May 13, 2007
Results First Received: November 30, 2012
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration