Trial Outcomes & Findings for Safety and Efficacy of Ranibizumab in Diabetic Macular Edema With Center Involvement (NCT NCT00284050)
NCT ID: NCT00284050
Last Updated: 2011-02-24
Results Overview
Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters as described in the Study Operations Manual.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
151 participants
Primary outcome timeframe
Baseline through the end of study (Month 12)
Results posted on
2011-02-24
Participant Flow
Participant milestones
| Measure |
Ranibizumab 0.3 mg
Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
Ranibizumab 0.5 mg
Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
Sham Injection
Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
49
|
|
Overall Study
COMPLETED
|
46
|
46
|
40
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
9
|
Reasons for withdrawal
| Measure |
Ranibizumab 0.3 mg
Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
Ranibizumab 0.5 mg
Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
Sham Injection
Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
3
|
|
Overall Study
Protocol Violation
|
0
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of Ranibizumab in Diabetic Macular Edema With Center Involvement
Baseline characteristics by cohort
| Measure |
Ranibizumab 0.3 mg
n=51 Participants
Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
Ranibizumab 0.5 mg
n=51 Participants
Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
Sham Injection
n=49 Participants
Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
63.2 years
STANDARD_DEVIATION 10.44 • n=5 Participants
|
62.8 years
STANDARD_DEVIATION 10.14 • n=7 Participants
|
65.0 years
STANDARD_DEVIATION 9.26 • n=5 Participants
|
63.6 years
STANDARD_DEVIATION 9.95 • n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline through the end of study (Month 12)Population: Full Analysis Set (FAS): All patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. A Last Observation Carried Forward (LOCF) approach was used; missing values were replaced by the mean of the last observation before and the first observation after the missing time-point.
Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters as described in the Study Operations Manual.
Outcome measures
| Measure |
Ranibizumab 0.3 mg
n=51 Participants
Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
Ranibizumab 0.5 mg
n=51 Participants
Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
Sham Injection
n=49 Participants
Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
|---|---|---|---|
|
Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12
|
9.2 Letters
Standard Deviation 5.60
|
6.4 Letters
Standard Deviation 9.21
|
-0.1 Letters
Standard Deviation 9.77
|
PRIMARY outcome
Timeframe: Baseline through the end of study (Month 12)Population: Full Analysis Set (FAS): All patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. A Last Observation Carried Forward (LOCF) approach was used; missing values were replaced by the mean of the last observation before and the first observation after the missing time-point.
Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters as described in the Study Operations Manual.
Outcome measures
| Measure |
Ranibizumab 0.3 mg
n=51 Participants
Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
Ranibizumab 0.5 mg
n=51 Participants
Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
Sham Injection
n=49 Participants
Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
|---|---|---|---|
|
Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye at Month 12
|
11.8 Letters
Standard Deviation 6.59
|
8.8 Letters
Standard Deviation 10.99
|
-1.4 Letters
Standard Deviation 14.16
|
SECONDARY outcome
Timeframe: Baseline through the end of study (Month 12)Population: Full Analysis Set (FAS): All patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. A Last Observation Carried Forward (LOCF) approach was used; missing values were replaced by the mean of the last observation before and the first observation after the missing time-point.
Optical Coherence Tomography (OCT) was assessed on both eyes at every study visit. These assessments were performed by trained personnel at the sites. OCT imaging was performed using the Zeiss Humphrey System Model 2000 (or later) with version A6.1 software running under Windows 95 or Windows 98. The analysis of the OCT images were performed by the Photographic Reading Center which provided a study manual and training materials. OCT operators, systems and software were certified prior to any evaluation of study patients.
Outcome measures
| Measure |
Ranibizumab 0.3 mg
n=51 Participants
Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
Ranibizumab 0.5 mg
n=51 Participants
Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
Sham Injection
n=49 Participants
Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
|---|---|---|---|
|
Mean Change From Baseline in Central Retinal Thickness (µm) of the Study Eye at Month 12
|
-200.7 µm
Standard Deviation 122.18
|
-187.6 µm
Standard Deviation 147.82
|
-48.4 µm
Standard Deviation 153.43
|
Adverse Events
Ranibizumab 0.3 mg
Serious events: 9 serious events
Other events: 37 other events
Deaths: 0 deaths
Ranibizumab 0.5 mg
Serious events: 9 serious events
Other events: 43 other events
Deaths: 0 deaths
Sham Injection
Serious events: 9 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ranibizumab 0.3 mg
n=51 participants at risk
Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
Ranibizumab 0.5 mg
n=51 participants at risk
Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
Sham Injection
n=49 participants at risk
Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
1/51
|
0.00%
0/51
|
0.00%
0/49
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/51
|
0.00%
0/51
|
2.0%
1/49
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/51
|
2.0%
1/51
|
2.0%
1/49
|
|
Eye disorders
Endophthalmitis (Study eye)
|
2.0%
1/51
|
2.0%
1/51
|
0.00%
0/49
|
|
Eye disorders
Retinal artery occlusion (Study eye)
|
0.00%
0/51
|
2.0%
1/51
|
0.00%
0/49
|
|
Eye disorders
Retinal detachment (Study eye)
|
0.00%
0/51
|
0.00%
0/51
|
2.0%
1/49
|
|
Eye disorders
Retinal ischaemia (Study eye)
|
0.00%
0/51
|
2.0%
1/51
|
0.00%
0/49
|
|
Eye disorders
Vitreous haemorrhage (Study eye)
|
2.0%
1/51
|
0.00%
0/51
|
0.00%
0/49
|
|
General disorders
Pitting oedema
|
0.00%
0/51
|
0.00%
0/51
|
2.0%
1/49
|
|
Infections and infestations
Cellulitis
|
0.00%
0/51
|
0.00%
0/51
|
2.0%
1/49
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/51
|
0.00%
0/51
|
2.0%
1/49
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/51
|
0.00%
0/51
|
2.0%
1/49
|
|
Infections and infestations
Gastroenteritis viral
|
2.0%
1/51
|
0.00%
0/51
|
0.00%
0/49
|
|
Infections and infestations
Infected epidermal cyst
|
0.00%
0/51
|
2.0%
1/51
|
0.00%
0/49
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
2.0%
1/51
|
0.00%
0/51
|
0.00%
0/49
|
|
Injury, poisoning and procedural complications
Concussion
|
2.0%
1/51
|
0.00%
0/51
|
0.00%
0/49
|
|
Injury, poisoning and procedural complications
Radius fracture
|
2.0%
1/51
|
0.00%
0/51
|
0.00%
0/49
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
2.0%
1/51
|
0.00%
0/51
|
0.00%
0/49
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/51
|
0.00%
0/51
|
2.0%
1/49
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.0%
1/51
|
0.00%
0/51
|
0.00%
0/49
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.0%
1/51
|
2.0%
1/51
|
0.00%
0/49
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/51
|
0.00%
0/51
|
2.0%
1/49
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
2.0%
1/51
|
0.00%
0/51
|
0.00%
0/49
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
1/51
|
0.00%
0/51
|
0.00%
0/49
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
2.0%
1/51
|
0.00%
0/51
|
0.00%
0/49
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
2.0%
1/51
|
0.00%
0/51
|
0.00%
0/49
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/51
|
2.0%
1/51
|
0.00%
0/49
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/51
|
2.0%
1/51
|
0.00%
0/49
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/51
|
0.00%
0/51
|
2.0%
1/49
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/51
|
2.0%
1/51
|
2.0%
1/49
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/51
|
0.00%
0/51
|
2.0%
1/49
|
|
Vascular disorders
Hypertension
|
0.00%
0/51
|
0.00%
0/51
|
2.0%
1/49
|
Other adverse events
| Measure |
Ranibizumab 0.3 mg
n=51 participants at risk
Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
Ranibizumab 0.5 mg
n=51 participants at risk
Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
Sham Injection
n=49 participants at risk
Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
|
|---|---|---|---|
|
Eye disorders
Cataract (Fellow eye)
|
0.00%
0/51
|
7.8%
4/51
|
4.1%
2/49
|
|
Eye disorders
Conjunctival haemorrhage (Study eye)
|
19.6%
10/51
|
25.5%
13/51
|
14.3%
7/49
|
|
Eye disorders
Conjunctival hyperaemia (Study eye)
|
3.9%
2/51
|
2.0%
1/51
|
6.1%
3/49
|
|
Eye disorders
Conjunctivitis (Fellow eye)
|
2.0%
1/51
|
0.00%
0/51
|
8.2%
4/49
|
|
Eye disorders
Conjunctivitis (Study eye)
|
2.0%
1/51
|
2.0%
1/51
|
8.2%
4/49
|
|
Eye disorders
Corneal disorder (Study eye)
|
5.9%
3/51
|
3.9%
2/51
|
0.00%
0/49
|
|
Eye disorders
Eye irritation (Study eye)
|
5.9%
3/51
|
2.0%
1/51
|
2.0%
1/49
|
|
Eye disorders
Eye pain (Study eye)
|
17.6%
9/51
|
17.6%
9/51
|
20.4%
10/49
|
|
Eye disorders
Eye pruritus (Study eye)
|
5.9%
3/51
|
3.9%
2/51
|
4.1%
2/49
|
|
Eye disorders
Eyelid oedema (Study eye)
|
2.0%
1/51
|
0.00%
0/51
|
6.1%
3/49
|
|
Eye disorders
Foreign body sensation in eyes (Study eye)
|
5.9%
3/51
|
5.9%
3/51
|
2.0%
1/49
|
|
Eye disorders
Lacrimation increased (Study eye)
|
7.8%
4/51
|
7.8%
4/51
|
0.00%
0/49
|
|
Eye disorders
Macular oedema (Fellow eye)
|
5.9%
3/51
|
3.9%
2/51
|
0.00%
0/49
|
|
Eye disorders
Ocular hyperaemia (Study eye)
|
3.9%
2/51
|
3.9%
2/51
|
8.2%
4/49
|
|
Eye disorders
Retinal disorder (Study eye)
|
5.9%
3/51
|
2.0%
1/51
|
0.00%
0/49
|
|
Eye disorders
Retinal exudates (Study eye)
|
3.9%
2/51
|
2.0%
1/51
|
8.2%
4/49
|
|
Eye disorders
Retinal haemorrhage (Study eye)
|
2.0%
1/51
|
3.9%
2/51
|
6.1%
3/49
|
|
Eye disorders
Visual acuity reduced (Study eye)
|
2.0%
1/51
|
11.8%
6/51
|
10.2%
5/49
|
|
Eye disorders
Visual disturbance (Study eye)
|
5.9%
3/51
|
2.0%
1/51
|
2.0%
1/49
|
|
Eye disorders
Vitreous floaters (Study eye)
|
2.0%
1/51
|
15.7%
8/51
|
0.00%
0/49
|
|
Eye disorders
Vitreous haemorrhage (Fellow eye)
|
5.9%
3/51
|
7.8%
4/51
|
6.1%
3/49
|
|
Eye disorders
Vitreous haemorrhage (Study eye)
|
0.00%
0/51
|
7.8%
4/51
|
0.00%
0/49
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/51
|
2.0%
1/51
|
6.1%
3/49
|
|
Infections and infestations
Bronchitis
|
2.0%
1/51
|
5.9%
3/51
|
4.1%
2/49
|
|
Infections and infestations
Influenza
|
3.9%
2/51
|
5.9%
3/51
|
2.0%
1/49
|
|
Infections and infestations
Nasopharyngitis
|
9.8%
5/51
|
9.8%
5/51
|
2.0%
1/49
|
|
Investigations
Intraocular pressure increased (Fellow eye)
|
2.0%
1/51
|
5.9%
3/51
|
0.00%
0/49
|
|
Investigations
Intraocular pressure increased (Study eye)
|
11.8%
6/51
|
29.4%
15/51
|
2.0%
1/49
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/51
|
5.9%
3/51
|
4.1%
2/49
|
|
Vascular disorders
Hypertension
|
5.9%
3/51
|
7.8%
4/51
|
6.1%
3/49
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862 778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER