Trial Outcomes & Findings for Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion (NCT NCT01535261)
NCT ID: NCT01535261
Last Updated: 2016-10-27
Results Overview
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement
COMPLETED
PHASE3
357 participants
Baseline to month 12
2016-10-27
Participant Flow
No data were excluded from the Full Analysis Set (FAS )analyses because of protocol deviations.
Participant milestones
| Measure |
Ranibizumab Arm
Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
|
|---|---|
|
Overall Study
STARTED
|
357
|
|
Overall Study
COMPLETED
|
307
|
|
Overall Study
NOT COMPLETED
|
50
|
Reasons for withdrawal
| Measure |
Ranibizumab Arm
Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
|
|---|---|
|
Overall Study
Physician Decision
|
8
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Death
|
5
|
|
Overall Study
Lost to Follow-up
|
8
|
|
Overall Study
Withdrawal by Subject
|
14
|
|
Overall Study
Adverse Event
|
12
|
Baseline Characteristics
Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion
Baseline characteristics by cohort
| Measure |
Ranibizumab Arm
n=357 Participants
Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
|
|---|---|
|
Age, Continuous
|
65.5 Years
STANDARD_DEVIATION 12.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
229 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to month 12Population: The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. One patient was excluded from the FAS for not having ≥ 1 post-baseline study eye VA assessment.
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement
Outcome measures
| Measure |
Ranibizumab Arm
n=356 Participants
Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
|
|---|---|
|
Mean Change in Best Corrected Visual Acuity (BCVA) at Month 12 Compared to Baseline
|
12.3 Letters
Standard Deviation 16.72
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. One patient was excluded from the FAS for not having ≥ 1 post-baseline study eye VA assessment.
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement
Outcome measures
| Measure |
Ranibizumab Arm
n=356 Participants
Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
|
|---|---|
|
Mean Change in Best Corrected Visual Acuity (BCVA) at Month 24 Compared to Baseline
|
12.1 Letters
Standard Deviation 18.60
|
SECONDARY outcome
Timeframe: Baseline and Month 1 to 12 or Month 24Population: The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. One patient was excluded from the FAS for not having ≥ 1 post-baseline study eye VA assessment.
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 12 (or Month 24). Then, mean average change is calculated as the average of average changes across all patients.
Outcome measures
| Measure |
Ranibizumab Arm
n=356 Participants
Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
|
|---|---|
|
Mean Average Change in Best Corrected Visual Acuity (BCVA From Baseline Month 12 and Month 24
Month 12
|
11.8 letters
Standard Deviation 12.44
|
|
Mean Average Change in Best Corrected Visual Acuity (BCVA From Baseline Month 12 and Month 24
Month 24
|
12.1 letters
Standard Deviation 14.20
|
SECONDARY outcome
Timeframe: Month 12 and Month 24Population: Full analysis set with use of LOCF consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. The number of patients shown was with a value at treatment interruption and an average for the post treatment interruption visits.
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. Stability in visual acuity after treatment interruption indicates longer duration of the drug efficacy
Outcome measures
| Measure |
Ranibizumab Arm
n=356 Participants
Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
|
|---|---|
|
Mean Average Change in BCVA From First Treatment Interruption (Due to BCVA Stabilization) to Month 12 and Month 24
Month 12 (n=310)
|
-2.7 Letters
Standard Deviation 8.04
|
|
Mean Average Change in BCVA From First Treatment Interruption (Due to BCVA Stabilization) to Month 12 and Month 24
Month 24 (n=331)
|
-2.5 Letters
Standard Deviation 8.95
|
SECONDARY outcome
Timeframe: Month 12 and Month 24Population: The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. No data were excluded from the FAS analyses because of protocol deviations.
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at month 12 as compared with baseline
Outcome measures
| Measure |
Ranibizumab Arm
n=356 Participants
Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
|
|---|---|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 and Month 24 in the Study Eye
BCVA improvement of >= 1 (Month 12)
|
296 Letters
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 and Month 24 in the Study Eye
BCVA improvement of >= 5 (Month 12)
|
275 Letters
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 and Month 24 in the Study Eye
BCVA improvement of >= 10 (Month 12)
|
227 Letters
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 and Month 24 in the Study Eye
BCVA improvement of >= 15 (Month 12)
|
175 Letters
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 and Month 24 in the Study Eye
BCVA improvement of >= 30 (Month 12)
|
32 Letters
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 and Month 24 in the Study Eye
BCVA improvement of >= 1 (Month 24)
|
290 Letters
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 and Month 24 in the Study Eye
BCVA improvement of >= 5 (Month 24)
|
265 Letters
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 and Month 24 in the Study Eye
BCVA improvement of >= 10 (Month 24)
|
224 Letters
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 and Month 24 in the Study Eye
BCVA improvement of >= 15 (Month 24)
|
175 Letters
|
|
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 and Month 24 in the Study Eye
BCVA improvement of >= 30 (Month 24)
|
44 Letters
|
SECONDARY outcome
Timeframe: Month 12 and Month 24Population: The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. No data were excluded from the FAS analyses because of protocol deviations.
Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at month 12 and month 24 indicates a positive outcome.
Outcome measures
| Measure |
Ranibizumab Arm
n=356 Participants
Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
|
|---|---|
|
Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 and Month 24
Month 12
|
169 Letters
|
|
Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 and Month 24
Month 24
|
161 Letters
|
SECONDARY outcome
Timeframe: Baseline, Month 12 and Month 24Population: The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. No data were excluded from the FAS analyses because of protocol deviations.
Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation
Outcome measures
| Measure |
Ranibizumab Arm
n=347 Participants
Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
|
|---|---|
|
Mean Change in Central Reading Center (CRC)-Assessed Central Subfield Thickness (CSFT) From Month 12 and Month 24 Compared to Baseline
Change from Baseline at Month 12
|
-335.7 Microns
Standard Deviation 285.02
|
|
Mean Change in Central Reading Center (CRC)-Assessed Central Subfield Thickness (CSFT) From Month 12 and Month 24 Compared to Baseline
Change from Baseline at Month 24
|
-349.1 Microns
Standard Deviation 275.35
|
SECONDARY outcome
Timeframe: Month 12 and Month 24Population: The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. The number of patients shown was with a value for both baseline and the post-baseline visit.
The survey consists of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranges from 0 (worst) to 100 which indicates the best possible response. The composite score and score of each of each construct also range from 0 to 100 as they are calculated as total scores divided by the number of questions. The higher the values of total scores represent better outcome. Scores per visit and of the change descriptively by visit.
Outcome measures
| Measure |
Ranibizumab Arm
n=350 Participants
Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
|
|---|---|
|
Mean Change in Patient-reported Outcomes in NEI-VFQ-25 Composite and Subscale Scores at Month 12 and Month 24 Compared to Baseline
Change from baseline at Month 12
|
6.9 Score on a scale
Standard Deviation 12.65
|
|
Mean Change in Patient-reported Outcomes in NEI-VFQ-25 Composite and Subscale Scores at Month 12 and Month 24 Compared to Baseline
Change from baseline at Month 24
|
6.6 Score on a scale
Standard Deviation 14.03
|
Adverse Events
Ranibizumab 0.5mg
Serious adverse events
| Measure |
Ranibizumab 0.5mg
n=357 participants at risk
Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.28%
1/357
|
|
Cardiac disorders
Angina pectoris
|
0.28%
1/357
|
|
Cardiac disorders
Atrial fibrillation
|
0.84%
3/357
|
|
Cardiac disorders
Cardiac failure
|
0.84%
3/357
|
|
Cardiac disorders
Cardiac failure acute
|
0.28%
1/357
|
|
Cardiac disorders
Cardiac failure congestive
|
0.84%
3/357
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.28%
1/357
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.28%
1/357
|
|
Cardiac disorders
Myocardial infarction
|
0.84%
3/357
|
|
Cardiac disorders
Right ventricular failure
|
0.28%
1/357
|
|
Cardiac disorders
Sinus tachycardia
|
0.28%
1/357
|
|
Ear and labyrinth disorders
Vertigo
|
0.28%
1/357
|
|
Eye disorders
Cataract (Fellow untreated eye)
|
0.28%
1/357
|
|
Eye disorders
Cataract (Study eye)
|
0.28%
1/357
|
|
Eye disorders
Glaucoma (Fellow untreated eye)
|
0.28%
1/357
|
|
Eye disorders
Glaucoma (Study eye)
|
0.56%
2/357
|
|
Eye disorders
Hyphaema (Fellow untreated eye)
|
0.28%
1/357
|
|
Eye disorders
Hyphaema (Study eye)
|
0.28%
1/357
|
|
Eye disorders
Myopia (Study eye)
|
0.28%
1/357
|
|
Eye disorders
Retinal haemorrhage (Study eye)
|
0.28%
1/357
|
|
Eye disorders
Retinal ischaemia (Study eye)
|
0.56%
2/357
|
|
Eye disorders
Retinal vascular thrombosis (Study eye)
|
0.28%
1/357
|
|
Eye disorders
Visual acuity reduced (Study eye)
|
0.56%
2/357
|
|
Eye disorders
Vitreous haemorrhage (Fellow untreated eye)
|
0.28%
1/357
|
|
Eye disorders
Vitreous haemorrhage (Study eye)
|
0.28%
1/357
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.28%
1/357
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.28%
1/357
|
|
Gastrointestinal disorders
Colitis
|
0.28%
1/357
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.28%
1/357
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.28%
1/357
|
|
Gastrointestinal disorders
Gastrointestinal polyp haemorrhage
|
0.28%
1/357
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.28%
1/357
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.28%
1/357
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.28%
1/357
|
|
Gastrointestinal disorders
Pancreatitis
|
0.28%
1/357
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.56%
2/357
|
|
General disorders
Chest pain
|
0.28%
1/357
|
|
General disorders
Death
|
0.28%
1/357
|
|
General disorders
Non-cardiac chest pain
|
0.28%
1/357
|
|
Hepatobiliary disorders
Cholecystitis
|
0.28%
1/357
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.28%
1/357
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.28%
1/357
|
|
Infections and infestations
Appendicitis
|
0.28%
1/357
|
|
Infections and infestations
Febrile infection
|
0.28%
1/357
|
|
Infections and infestations
Gangrene
|
0.28%
1/357
|
|
Infections and infestations
Lower respiratory tract infection
|
0.84%
3/357
|
|
Infections and infestations
Ophthalmic herpes zoster (Fellow untreated eye)
|
0.28%
1/357
|
|
Infections and infestations
Pneumonia
|
0.84%
3/357
|
|
Infections and infestations
Pneumonia viral
|
0.28%
1/357
|
|
Infections and infestations
Sepsis
|
0.28%
1/357
|
|
Infections and infestations
Septic shock
|
0.28%
1/357
|
|
Infections and infestations
Urosepsis
|
0.28%
1/357
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.56%
2/357
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.28%
1/357
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.28%
1/357
|
|
Injury, poisoning and procedural complications
Laceration
|
0.28%
1/357
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.28%
1/357
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.28%
1/357
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.28%
1/357
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.28%
1/357
|
|
Investigations
Intraocular pressure increased (Study eye)
|
0.28%
1/357
|
|
Investigations
Visual acuity tests abnormal (Study eye)
|
0.28%
1/357
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.28%
1/357
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.28%
1/357
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.28%
1/357
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.28%
1/357
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.28%
1/357
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.56%
2/357
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.28%
1/357
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.56%
2/357
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.28%
1/357
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.28%
1/357
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.28%
1/357
|
|
Nervous system disorders
Brain hypoxia
|
0.28%
1/357
|
|
Nervous system disorders
Cerebrovascular accident
|
0.56%
2/357
|
|
Psychiatric disorders
Anxiety
|
0.56%
2/357
|
|
Psychiatric disorders
Depression
|
0.28%
1/357
|
|
Psychiatric disorders
Major depression
|
0.28%
1/357
|
|
Renal and urinary disorders
Renal failure
|
0.28%
1/357
|
|
Renal and urinary disorders
Renal failure acute
|
0.56%
2/357
|
|
Renal and urinary disorders
Renal mass
|
0.28%
1/357
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.28%
1/357
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.28%
1/357
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.56%
2/357
|
|
Vascular disorders
Aneurysm ruptured
|
0.28%
1/357
|
|
Vascular disorders
Angiopathy
|
0.28%
1/357
|
|
Vascular disorders
Diabetic vascular disorder
|
0.28%
1/357
|
|
Vascular disorders
Hypertension
|
0.56%
2/357
|
|
Vascular disorders
Hypertensive crisis
|
0.28%
1/357
|
|
Vascular disorders
Hypotension
|
0.28%
1/357
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.28%
1/357
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.28%
1/357
|
Other adverse events
| Measure |
Ranibizumab 0.5mg
n=357 participants at risk
Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
|
|---|---|
|
Eye disorders
Blepharitis (Study eye)
|
3.4%
12/357
|
|
Eye disorders
Cataract (Fellow untreated eye)
|
3.1%
11/357
|
|
Eye disorders
Cataract (Study eye)
|
4.2%
15/357
|
|
Eye disorders
Conjunctival haemorrhage (Study eye)
|
6.7%
24/357
|
|
Eye disorders
Dry eye (Fellow untreated eye)
|
5.3%
19/357
|
|
Eye disorders
Dry eye (Study eye)
|
6.2%
22/357
|
|
Eye disorders
Eye pain (Study eye)
|
7.0%
25/357
|
|
Eye disorders
Eyelid oedema (Study eye)
|
2.5%
9/357
|
|
Eye disorders
Glaucoma (Fellow untreated eye)
|
2.8%
10/357
|
|
Eye disorders
Glaucoma (Study eye)
|
3.1%
11/357
|
|
Eye disorders
Macular fibrosis (Study eye)
|
4.2%
15/357
|
|
Eye disorders
Macular oedema (Study eye)
|
5.3%
19/357
|
|
Eye disorders
Ocular discomfort (Study eye)
|
2.8%
10/357
|
|
Eye disorders
Ocular hyperaemia (Study eye)
|
2.5%
9/357
|
|
Eye disorders
Ocular hypertension (Fellow untreated eye)
|
2.2%
8/357
|
|
Eye disorders
Ocular hypertension (Study eye)
|
7.3%
26/357
|
|
Eye disorders
Vision blurred (Study eye)
|
5.0%
18/357
|
|
Eye disorders
Visual acuity reduced (Study eye)
|
5.9%
21/357
|
|
Eye disorders
Vitreous detachment (Study eye)
|
3.4%
12/357
|
|
Eye disorders
Vitreous floaters (Study eye)
|
5.3%
19/357
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
11/357
|
|
General disorders
Injection site pain (Study eye)
|
3.1%
11/357
|
|
Infections and infestations
Bronchitis
|
4.2%
15/357
|
|
Infections and infestations
Conjunctivitis (Fellow untreated eye)
|
2.2%
8/357
|
|
Infections and infestations
Conjunctivitis (Study eye)
|
2.8%
10/357
|
|
Infections and infestations
Influenza
|
4.8%
17/357
|
|
Infections and infestations
Lower respiratory tract infection
|
2.2%
8/357
|
|
Infections and infestations
Nasopharyngitis
|
10.9%
39/357
|
|
Infections and infestations
Pneumonia
|
2.2%
8/357
|
|
Infections and infestations
Sinusitis
|
2.5%
9/357
|
|
Infections and infestations
Tooth infection
|
2.5%
9/357
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
12/357
|
|
Infections and infestations
Urinary tract infection
|
2.5%
9/357
|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
15/357
|
|
Investigations
Intraocular pressure increased (Fellow untreated eye)
|
3.1%
11/357
|
|
Investigations
Intraocular pressure increased (Study eye)
|
12.0%
43/357
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
9/357
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.6%
13/357
|
|
Nervous system disorders
Dizziness
|
3.1%
11/357
|
|
Nervous system disorders
Headache
|
5.9%
21/357
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
13/357
|
|
Vascular disorders
Hypertension
|
11.2%
40/357
|
Additional Information
Study Director
Novartis
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 or disclosure of trial results in their entirety
- Publication restrictions are in place
Restriction type: OTHER