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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00473382
First received: May 13, 2007
Last updated: August 25, 2014
Last verified: August 2014
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
No text entered.

Reporting Groups
  Description
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. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
Ranibizumab 0.3 mg Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
Ranibizumab 0.5 mg Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.

Participant Flow for 3 periods

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

Period 2:   Open-label Extension Through Month 48
    Sham Injection/Ranibizumab 0.5 mg   Ranibizumab 0.3 mg   Ranibizumab 0.5 mg
STARTED   88 [1]   83 [1]   84 [1] 
COMPLETED   38   42   37 
NOT COMPLETED   50   41   47 
Adverse Event                0                0                1 
Death                1                3                3 
Lost to Follow-up                1                2                1 
Subject's Decision                5                1                6 
Sponsor’s Decision to Terminate Study                41                34                36 
Subject Required Other Intervention                2                1                0 
[1] Not all participants who completed the core study entered the optional open-label extension.

Period 3:   Open-label Extension Through Month 60
    Sham Injection/Ranibizumab 0.5 mg   Ranibizumab 0.3 mg   Ranibizumab 0.5 mg
STARTED   88 [1]   83 [1]   84 [1] 
COMPLETED   2   1   2 
NOT COMPLETED   86   82   82 
Adverse Event                0                0                2 
Death                1                7                4 
Lost to Follow-up                1                3                1 
Subject's Decision                7                1                6 
Sponsor’s Decision to Terminate Study                75                70                69 
Subject Required Other Intervention                2                1                0 
[1] Not all participants who completed the core study entered the optional open-label extension.



  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.
The Baseline Characteristics of the patients enrolled in the open-label extension phase (N=88, 83, 84 patients originally randomized to the ranibizumab 0.3 mg, ranibizumab 0.5 mg, and sham injection groups, respectively) were similar to the Baseline Characteristics of the patients enrolled in the core study.

Reporting Groups
  Description
Ranibizumab 0.3 mg Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
Ranibizumab 0.5 mg Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional 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
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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, 36, and 48   [ Time Frame: Baseline to Month 48 ]

3.  Secondary:   Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Months 24, 36, and 48   [ Time Frame: Months 24, 36, and 48 ]

4.  Secondary:   Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 24, 36, and 48   [ Time Frame: Baseline to Month 48 ]

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 Month 36 ]

6.  Secondary:   Mean Change From Baseline in Central Foveal Thickness at Months 24, 36, and 48   [ Time Frame: Baseline to Month 48 ]

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 Month 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 Month 36 ]

10.  Secondary:   Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 36 and 48   [ Time Frame: Baseline to Month 48 ]

11.  Secondary:   Mean Change From Month 36 in Best Corrected Visual Acuity (BCVA) Score in the Study Eye at Month 48   [ Time Frame: Month 36 to Month 48 ]

12.  Secondary:   Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score in the Study Eye From Month 36 at Month 48   [ Time Frame: Month 36 to Month 48 ]

13.  Secondary:   Mean Change From Month 36 in Central Foveal Thickness in the Study Eye at Month 48   [ Time Frame: Month 36 to Month 48 ]


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame Adverse events were recorded from the first day of treatment through Month 60. The sham Months 0-36 group includes patients randomized to sham. The sham Months 0-24 group includes patients who received sham during the first 24 months of the study.
Additional Description

The adverse events tables have been updated to MedDRA version 15.1 to include safety data from the open-label extension phase. Late reported adverse events from the 36-month period have also been included.

Safety evaluable population: All randomized patients who received at least 1 study treatment.


Frequency Threshold
Threshold above which other adverse events are reported   5  

Reporting Groups
  Description
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.
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.
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 37-60 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. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
Ranibizumab 0.3 mg - Months 37-60 Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
Ranibizumab 0.5 mg - Months 37-60 Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).

Other Adverse Events
    Sham Injection - Months 0-24   Sham Injection/Ranibizumab 0.5 mg - Months 0-36   Ranibizumab 0.3 mg - Months 0-36   Ranibizumab 0.5 mg - Months 0-36   Sham Injection/Ranibizumab 0.5 mg - Months 37-60   Ranibizumab 0.3 mg - Months 37-60   Ranibizumab 0.5 mg - Months 37-60
Total, other (not including serious) adverse events               
# participants affected / at risk   123/127 (96.85%)   123/127 (96.85%)   120/125 (96.00%)   121/124 (97.58%)   65/88 (73.86%)   63/83 (75.90%)   62/84 (73.81%) 
Blood and lymphatic system disorders               
Anaemia † 1               
# participants affected / at risk   13/127 (10.24%)   16/127 (12.60%)   13/125 (10.40%)   22/124 (17.74%)   3/88 (3.41%)   2/83 (2.41%)   3/84 (3.57%) 
Cardiac disorders               
Atrial fibrillation † 1               
# participants affected / at risk   4/127 (3.15%)   7/127 (5.51%)   4/125 (3.20%)   4/124 (3.23%)   2/88 (2.27%)   3/83 (3.61%)   1/84 (1.19%) 
Cardiac failure congestive † 1               
# participants affected / at risk   7/127 (5.51%)   8/127 (6.30%)   7/125 (5.60%)   3/124 (2.42%)   0/88 (0.00%)   2/83 (2.41%)   2/84 (2.38%) 
Coronary artery disease † 1               
# participants affected / at risk   4/127 (3.15%)   8/127 (6.30%)   6/125 (4.80%)   4/124 (3.23%)   2/88 (2.27%)   0/83 (0.00%)   1/84 (1.19%) 
Endocrine disorders               
Hypothyroidism † 1               
# participants affected / at risk   5/127 (3.94%)   7/127 (5.51%)   2/125 (1.60%)   4/124 (3.23%)   1/88 (1.14%)   0/83 (0.00%)   0/84 (0.00%) 
Eye disorders               
Cataract (F) † 1 [3]               
# participants affected / at risk   29/127 (22.83%)   32/127 (25.20%)   38/125 (30.40%)   41/124 (33.06%)   5/88 (5.68%)   1/83 (1.20%)   3/84 (3.57%) 
Cataract (S) † 1 [4]               
# participants affected / at risk   35/127 (27.56%)   39/127 (30.71%)   31/125 (24.80%)   35/124 (28.23%)   5/88 (5.68%)   6/83 (7.23%)   5/84 (5.95%) 
Cataract cortical (F) † 1 [3]               
# participants affected / at risk   5/127 (3.94%)   8/127 (6.30%)   10/125 (8.00%)   3/124 (2.42%)   0/88 (0.00%)   1/83 (1.20%)   0/84 (0.00%) 
Cataract cortical (S) † 1 [4]               
# participants affected / at risk   5/127 (3.94%)   6/127 (4.72%)   8/125 (6.40%)   5/124 (4.03%)   3/88 (3.41%)   2/83 (2.41%)   1/84 (1.19%) 
Cataract nuclear (F) † 1 [3]               
# participants affected / at risk   1/127 (0.79%)   2/127 (1.57%)   10/125 (8.00%)   5/124 (4.03%)   0/88 (0.00%)   1/83 (1.20%)   0/84 (0.00%) 
Cataract nuclear (S) † 1 [4]               
# participants affected / at risk   3/127 (2.36%)   4/127 (3.15%)   6/125 (4.80%)   8/124 (6.45%)   1/88 (1.14%)   1/83 (1.20%)   1/84 (1.19%) 
Cataract subcapsular (F) † 1 [3]               
# participants affected / at risk   3/127 (2.36%)   3/127 (2.36%)   7/125 (5.60%)   8/124 (6.45%)   0/88 (0.00%)   1/83 (1.20%)   0/84 (0.00%) 
Conjunctival haemorrhage (F) † 1 [3]               
# participants affected / at risk   3/127 (2.36%)   11/127 (8.66%)   8/125 (6.40%)   14/124 (11.29%)   3/88 (3.41%)   2/83 (2.41%)   5/84 (5.95%) 
Conjunctival haemorrhage (S) † 1 [4]               
# participants affected / at risk   40/127 (31.50%)   45/127 (35.43%)   54/125 (43.20%)   63/124 (50.81%)   7/88 (7.95%)   4/83 (4.82%)   6/84 (7.14%) 
Diabetic retinal oedema (F) † 1 [3]               
# participants affected / at risk   19/127 (14.96%)   20/127 (15.75%)   25/125 (20.00%)   16/124 (12.90%)   2/88 (2.27%)   0/83 (0.00%)   1/84 (1.19%) 
Diabetic retinal oedema (S) † 1 [4]               
# participants affected / at risk   8/127 (6.30%)   8/127 (6.30%)   8/125 (6.40%)   3/124 (2.42%)   1/88 (1.14%)   1/83 (1.20%)   3/84 (3.57%) 
Diabetic retinopathy (F) † 1 [3]               
# participants affected / at risk   5/127 (3.94%)   5/127 (3.94%)   8/125 (6.40%)   10/124 (8.06%)   0/88 (0.00%)   2/83 (2.41%)   0/84 (0.00%) 
Dry eye (F) † 1 [3]               
# participants affected / at risk   8/127 (6.30%)   10/127 (7.87%)   5/125 (4.00%)   8/124 (6.45%)   5/88 (5.68%)   2/83 (2.41%)   1/84 (1.19%) 
Dry eye (S) † 1 [4]               
# participants affected / at risk   6/127 (4.72%)   8/127 (6.30%)   8/125 (6.40%)   9/124 (7.26%)   4/88 (4.55%)   3/83 (3.61%)   1/84 (1.19%) 
Eye irritation (S) † 1 [4]               
# participants affected / at risk   4/127 (3.15%)   6/127 (4.72%)   8/125 (6.40%)   7/124 (5.65%)   1/88 (1.14%)   1/83 (1.20%)   2/84 (2.38%) 
Eye pain (S) † 1 [4]               
# participants affected / at risk   10/127 (7.87%)   12/127 (9.45%)   14/125 (11.20%)   18/124 (14.52%)   0/88 (0.00%)   3/83 (3.61%)   1/84 (1.19%) 
Foreign body sensation in eyes (S) † 1 [4]               
# participants affected / at risk   7/127 (5.51%)   8/127 (6.30%)   10/125 (8.00%)   4/124 (3.23%)   1/88 (1.14%)   1/83 (1.20%)   1/84 (1.19%) 
Lacrimation increased (S) † 1 [4]               
# participants affected / at risk   4/127 (3.15%)   6/127 (4.72%)   7/125 (5.60%)   5/124 (4.03%)   0/88 (0.00%)   1/83 (1.20%)   0/84 (0.00%) 
Macular fibrosis (F) † 1 [3]               
# participants affected / at risk   5/127 (3.94%)   6/127 (4.72%)   13/125 (10.40%)   9/124 (7.26%)   1/88 (1.14%)   1/83 (1.20%)   1/84 (1.19%) 
Macular fibrosis (S) † 1 [4]               
# participants affected / at risk   11/127 (8.66%)   14/127 (11.02%)   7/125 (5.60%)   8/124 (6.45%)   4/88 (4.55%)   1/83 (1.20%)   3/84 (3.57%) 
Macular oedema (F) † 1 [3]               
# participants affected / at risk   28/127 (22.05%)   37/127 (29.13%)   46/125 (36.80%)   53/124 (42.74%)   10/88 (11.36%)   8/83 (9.64%)   9/84 (10.71%) 
Macular oedema (S) † 1 [4]               
# participants affected / at risk   26/127 (20.47%)   33/127 (25.98%)   32/125 (25.60%)   26/124 (20.97%)   9/88 (10.23%)   6/83 (7.23%)   9/84 (10.71%) 
Ocular hyperaemia (S) † 1 [4]               
# participants affected / at risk   10/127 (7.87%)   10/127 (7.87%)   5/125 (4.00%)   5/124 (4.03%)   0/88 (0.00%)   1/83 (1.20%)   1/84 (1.19%) 
Posterior capsule opacification (S) † 1 [4]               
# participants affected / at risk   4/127 (3.15%)   6/127 (4.72%)   7/125 (5.60%)   5/124 (4.03%)   0/88 (0.00%)   1/83 (1.20%)   1/84 (1.19%) 
Retinal exudates (F) † 1 [3]               
# participants affected / at risk   16/127 (12.60%)   18/127 (14.17%)   23/125 (18.40%)   21/124 (16.94%)   0/88 (0.00%)   2/83 (2.41%)   1/84 (1.19%) 
Retinal exudates (S) † 1 [4]               
# participants affected / at risk   15/127 (11.81%)   19/127 (14.96%)   22/125 (17.60%)   20/124 (16.13%)   2/88 (2.27%)   3/83 (3.61%)   4/84 (4.76%) 
Retinal haemorrhage (F) † 1 [3]               
# participants affected / at risk   20/127 (15.75%)   31/127 (24.41%)   32/125 (25.60%)   40/124 (32.26%)   6/88 (6.82%)   9/83 (10.84%)   8/84 (9.52%) 
Retinal haemorrhage (S) † 1 [4]               
# participants affected / at risk   22/127 (17.32%)   26/127 (20.47%)   22/125 (17.60%)   34/124 (27.42%)   4/88 (4.55%)   9/83 (10.84%)   7/84 (8.33%) 
Retinal neovascularisation (F) † 1 [3]               
# participants affected / at risk   10/127 (7.87%)   13/127 (10.24%)   13/125 (10.40%)   14/124 (11.29%)   3/88 (3.41%)   1/83 (1.20%)   3/84 (3.57%) 
Retinal neovascularisation (S) † 1 [4]               
# participants affected / at risk   7/127 (5.51%)   8/127 (6.30%)   1/125 (0.80%)   1/124 (0.81%)   0/88 (0.00%)   1/83 (1.20%)   1/84 (1.19%) 
Vision blurred (S) † 1 [4]               
# participants affected / at risk   5/127 (3.94%)   5/127 (3.94%)   10/125 (8.00%)   5/124 (4.03%)   1/88 (1.14%)   2/83 (2.41%)   0/84 (0.00%) 
Vitreous detachment (F) † 1 [3]               
# participants affected / at risk   19/127 (14.96%)   20/127 (15.75%)   13/125 (10.40%)   12/124 (9.68%)   1/88 (1.14%)   3/83 (3.61%)   1/84 (1.19%) 
Vitreous detachment (S) † 1 [4]               
# participants affected / at risk   19/127 (14.96%)   22/127 (17.32%)   14/125 (11.20%)   23/124 (18.55%)   2/88 (2.27%)   2/83 (2.41%)   1/84 (1.19%) 
Vitreous floaters (F) † 1 [3]               
# participants affected / at risk   7/127 (5.51%)   8/127 (6.30%)   3/125 (2.40%)   6/124 (4.84%)   2/88 (2.27%)   3/83 (3.61%)   4/84 (4.76%) 
Vitreous floaters (S) † 1 [4]               
# participants affected / at risk   4/127 (3.15%)   6/127 (4.72%)   10/125 (8.00%)   13/124 (10.48%)   4/88 (4.55%)   1/83 (1.20%)   3/84 (3.57%) 
Vitreous haemorrhage (F) † 1 [3]               
# participants affected / at risk   12/127 (9.45%)   16/127 (12.60%)   18/125 (14.40%)   14/124 (11.29%)   5/88 (5.68%)   4/83 (4.82%)   3/84 (3.57%) 
Vitreous haemorrhage (S) † 1 [4]               
# participants affected / at risk   16/127 (12.60%)   17/127 (13.39%)   3/125 (2.40%)   4/124 (3.23%)   2/88 (2.27%)   3/83 (3.61%)   1/84 (1.19%) 
Gastrointestinal disorders               
Constipation † 1               
# participants affected / at risk   7/127 (5.51%)   9/127 (7.09%)   14/125 (11.20%)   9/124 (7.26%)   2/88 (2.27%)   2/83 (2.41%)   5/84 (5.95%) 
Diarrhoea † 1               
# participants affected / at risk   6/127 (4.72%)   6/127 (4.72%)   3/125 (2.40%)   11/124 (8.87%)   1/88 (1.14%)   1/83 (1.20%)   1/84 (1.19%) 
Gastrooesophageal reflux disease † 1               
# participants affected / at risk   6/127 (4.72%)   6/127 (4.72%)   6/125 (4.80%)   10/124 (8.06%)   2/88 (2.27%)   1/83 (1.20%)   3/84 (3.57%) 
Nausea † 1               
# participants affected / at risk   14/127 (11.02%)   16/127 (12.60%)   14/125 (11.20%)   10/124 (8.06%)   3/88 (3.41%)   4/83 (4.82%)   2/84 (2.38%) 
Vomiting † 1               
# participants affected / at risk   9/127 (7.09%)   10/127 (7.87%)   6/125 (4.80%)   7/124 (5.65%)   0/88 (0.00%)   1/83 (1.20%)   2/84 (2.38%) 
General disorders               
Oedema peripheral † 1               
# participants affected / at risk   4/127 (3.15%)   4/127 (3.15%)   9/125 (7.20%)   8/124 (6.45%)   4/88 (4.55%)   2/83 (2.41%)   0/84 (0.00%) 
Immune system disorders               
Drug hypersensitivity † 1               
# participants affected / at risk   6/127 (4.72%)   7/127 (5.51%)   2/125 (1.60%)   1/124 (0.81%)   0/88 (0.00%)   0/83 (0.00%)   2/84 (2.38%) 
Seasonal allergy † 1               
# participants affected / at risk   5/127 (3.94%)   6/127 (4.72%)   12/125 (9.60%)   9/124 (7.26%)   1/88 (1.14%)   2/83 (2.41%)   0/84 (0.00%) 
Infections and infestations               
Bronchitis † 1               
# participants affected / at risk   4/127 (3.15%)   6/127 (4.72%)   8/125 (6.40%)   12/124 (9.68%)   0/88 (0.00%)   2/83 (2.41%)   1/84 (1.19%) 
Cellulitis † 1               
# participants affected / at risk   4/127 (3.15%)   9/127 (7.09%)   5/125 (4.00%)   4/124 (3.23%)   2/88 (2.27%)   0/83 (0.00%)   0/84 (0.00%) 
Influenza † 1               
# participants affected / at risk   7/127 (5.51%)   9/127 (7.09%)   10/125 (8.00%)   13/124 (10.48%)   3/88 (3.41%)   0/83 (0.00%)   3/84 (3.57%) 
Nasopharyngitis † 1               
# participants affected / at risk   6/127 (4.72%)   10/127 (7.87%)   16/125 (12.80%)   13/124 (10.48%)   4/88 (4.55%)   3/83 (3.61%)   3/84 (3.57%) 
Pneumonia † 1               
# participants affected / at risk   4/127 (3.15%)   6/127 (4.72%)   5/125 (4.00%)   8/124 (6.45%)   0/88 (0.00%)   0/83 (0.00%)   0/84 (0.00%) 
Sinusitis † 1               
# participants affected / at risk   12/127 (9.45%)   14/127 (11.02%)   9/125 (7.20%)   14/124 (11.29%)   4/88 (4.55%)   3/83 (3.61%)   2/84 (2.38%) 
Upper respiratory tract infection † 1               
# participants affected / at risk   12/127 (9.45%)   14/127 (11.02%)   12/125 (9.60%)   13/124 (10.48%)   3/88 (3.41%)   3/83 (3.61%)   2/84 (2.38%) 
Urinary tract infection † 1               
# participants affected / at risk   19/127 (14.96%)   24/127 (18.90%)   13/125 (10.40%)   17/124 (13.71%)   2/88 (2.27%)   5/83 (6.02%)   3/84 (3.57%) 
Injury, poisoning and procedural complications               
Corneal abrasion (S) † 1 [4]               
# participants affected / at risk   6/127 (4.72%)   8/127 (6.30%)   7/125 (5.60%)   4/124 (3.23%)   1/88 (1.14%)   0/83 (0.00%)   0/84 (0.00%) 
Fall † 1               
# participants affected / at risk   3/127 (2.36%)   8/127 (6.30%)   10/125 (8.00%)   2/124 (1.61%)   1/88 (1.14%)   1/83 (1.20%)   1/84 (1.19%) 
Procedural pain † 1               
# participants affected / at risk   2/127 (1.57%)   3/127 (2.36%)   1/125 (0.80%)   7/124 (5.65%)   0/88 (0.00%)   1/83 (1.20%)   0/84 (0.00%) 
Investigations               
Blood creatinine increased † 1               
# participants affected / at risk   5/127 (3.94%)   6/127 (4.72%)   8/125 (6.40%)   5/124 (4.03%)   1/88 (1.14%)   1/83 (1.20%)   0/84 (0.00%) 
Blood glucose increased † 1               
# participants affected / at risk   8/127 (6.30%)   9/127 (7.09%)   10/125 (8.00%)   9/124 (7.26%)   1/88 (1.14%)   1/83 (1.20%)   1/84 (1.19%) 
Intraocular pressure increased (F) † 1 [3]               
# participants affected / at risk   6/127 (4.72%)   7/127 (5.51%)   7/125 (5.60%)   12/124 (9.68%)   2/88 (2.27%)   1/83 (1.20%)   1/84 (1.19%) 
Intraocular pressure increased (S) † 1 [4]               
# participants affected / at risk   14/127 (11.02%)   17/127 (13.39%)   20/125 (16.00%)   25/124 (20.16%)   2/88 (2.27%)   2/83 (2.41%)   3/84 (3.57%) 
Blood urea increased † 1               
# participants affected / at risk   5/127 (3.94%)   6/127 (4.72%)   8/125 (6.40%)   5/124 (4.03%)   1/88 (1.14%)   0/83 (0.00%)   0/84 (0.00%) 
Metabolism and nutrition disorders               
Diabetes mellitus † 1               
# participants affected / at risk   22/127 (17.32%)   25/127 (19.69%)   19/125 (15.20%)   22/124 (17.74%)   5/88 (5.68%)   6/83 (7.23%)   5/84 (5.95%) 
Hypercholesterolaemia † 1               
# participants affected / at risk   7/127 (5.51%)   8/127 (6.30%)   13/125 (10.40%)   4/124 (3.23%)   2/88 (2.27%)   1/83 (1.20%)   1/84 (1.19%) 
Hyperkalaemia † 1               
# participants affected / at risk   4/127 (3.15%)   4/127 (3.15%)   5/125 (4.00%)   8/124 (6.45%)   2/88 (2.27%)   1/83 (1.20%)   1/84 (1.19%) 
Hyperlipidaemia † 1               
# participants affected / at risk   3/127 (2.36%)   4/127 (3.15%)   7/125 (5.60%)   6/124 (4.84%)   2/88 (2.27%)   1/83 (1.20%)   1/84 (1.19%) 
Hypoglycaemia † 1               
# participants affected / at risk   6/127 (4.72%)   7/127 (5.51%)   5/125 (4.00%)   2/124 (1.61%)   3/88 (3.41%)   0/83 (0.00%)   3/84 (3.57%) 
Musculoskeletal and connective tissue disorders               
Back pain † 1               
# participants affected / at risk   11/127 (8.66%)   14/127 (11.02%)   5/125 (4.00%)   9/124 (7.26%)   0/88 (0.00%)   0/83 (0.00%)   2/84 (2.38%) 
Nervous system disorders               
Diabetic neuropathy † 1               
# participants affected / at risk   4/127 (3.15%)   6/127 (4.72%)   7/125 (5.60%)   1/124 (0.81%)   0/88 (0.00%)   0/83 (0.00%)   0/84 (0.00%) 
Dizziness † 1               
# participants affected / at risk   4/127 (3.15%)   5/127 (3.94%)   5/125 (4.00%)   7/124 (5.65%)   1/88 (1.14%)   3/83 (3.61%)   1/84 (1.19%) 
Headache † 1               
# participants affected / at risk   7/127 (5.51%)   10/127 (7.87%)   10/125 (8.00%)   7/124 (5.65%)   0/88 (0.00%)   4/83 (4.82%)   0/84 (0.00%) 
Neuropathy peripheral † 1               
# participants affected / at risk   4/127 (3.15%)   6/127 (4.72%)   9/125 (7.20%)   4/124 (3.23%)   2/88 (2.27%)   2/83 (2.41%)   1/84 (1.19%) 
Psychiatric disorders               
Anxiety † 1               
# participants affected / at risk   8/127 (6.30%)   8/127 (6.30%)   6/125 (4.80%)   3/124 (2.42%)   1/88 (1.14%)   2/83 (2.41%)   2/84 (2.38%) 
Renal and urinary disorders               
Renal failure † 1               
# participants affected / at risk   7/127 (5.51%)   7/127 (5.51%)   5/125 (4.00%)   12/124 (9.68%)   0/88 (0.00%)   1/83 (1.20%)   0/84 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Cough † 1               
# participants affected / at risk   8/127 (6.30%)   10/127 (7.87%)   17/125 (13.60%)   10/124 (8.06%)   2/88 (2.27%)   2/83 (2.41%)   4/84 (4.76%) 
Dyspnoea † 1               
# participants affected / at risk   7/127 (5.51%)   8/127 (6.30%)   3/125 (2.40%)   1/124 (0.81%)   2/88 (2.27%)   1/83 (1.20%)   1/84 (1.19%) 
Vascular disorders               
Hypertension † 1               
# participants affected / at risk   31/127 (24.41%)   35/127 (27.56%)   33/125 (26.40%)   38/124 (30.65%)   5/88 (5.68%)   3/83 (3.61%)   3/84 (3.57%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (15.1)
[3] (F)=fellow eye
[4] (S)=study eye



  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
e-mail: genentech@druginfo.com


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


Responsible Party: Genentech, Inc.
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 25, 2014
Health Authority: United States: Food and Drug Administration