Trial Outcomes & Findings for Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Central Retinal Vein Occlusion (CRVO) (NCT NCT01396083)
NCT ID: NCT01396083
Last Updated: 2016-09-27
Results Overview
the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6. 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 ETDRS visual acuity score of 85 is pproximately 20/20. An increased score indicates improvement in acuity
COMPLETED
PHASE3
243 participants
Baseline, month 6
2016-09-27
Participant Flow
Participant milestones
| Measure |
Ranibizumab
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
119
|
|
Overall Study
COMPLETED
|
113
|
72
|
|
Overall Study
NOT COMPLETED
|
11
|
47
|
Reasons for withdrawal
| Measure |
Ranibizumab
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
28
|
|
Overall Study
Unsatisfactory therapeutic effect
|
2
|
13
|
|
Overall Study
Consent withdrawn
|
4
|
5
|
|
Overall Study
Protocol deviation(s)
|
0
|
1
|
|
Overall Study
Abnormal laboratory value(s)
|
1
|
0
|
|
Overall Study
Administrative problems
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Central Retinal Vein Occlusion (CRVO)
Baseline characteristics by cohort
| Measure |
Ranibizumab
n=124 Participants
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=119 Participants
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 Years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
66.9 Years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
66.1 Years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, month 6Population: The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned
the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6. 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 ETDRS visual acuity score of 85 is pproximately 20/20. An increased score indicates improvement in acuity
Outcome measures
| Measure |
Ranibizumab
n=124 Participants
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=119 Participants
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Mean Average BCVA Change From Month 1 Through Month 6 to Baseline
|
14.6 Letters
Standard Deviation 11.8
|
4.8 Letters
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: Baseline, month 6Population: The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned
The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors
Outcome measures
| Measure |
Ranibizumab
n=124 Participants
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=119 Participants
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Mean BCVA Change at Month 6
|
14.78 Letters
Interval 11.24 to 18.32
|
-3.17 Letters
Interval -6.8 to 0.46
|
SECONDARY outcome
Timeframe: Baseline, 6 monthPopulation: The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned
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 ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the number of participants who gained 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline
Outcome measures
| Measure |
Ranibizumab
n=124 Participants
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=119 Participants
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters
Loss of ≥10 letters
|
4 Participants
|
35 Participants
|
|
Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters
Loss of ≥5 letters
|
5 Participants
|
40 Participants
|
|
Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters
Gain≥15 letters
|
73 Participants
|
22 Participants
|
|
Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters
Loss of ≥15 letters
|
1 Participants
|
31 Participants
|
|
Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters
Gain ≥10 letters
|
89 Participants
|
38 Participants
|
|
Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters
Gain ≥5 letters
|
104 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: Baseline, month 6Population: The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned
The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts
Outcome measures
| Measure |
Ranibizumab
n=124 Participants
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=119 Participants
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Time to Achieve a Significant Improvement ≥ 15 Letters
|
62 Time to event (Days)
Interval 56.0 to 91.0
|
98 Time to event (Days)
Interval 63.0 to
NA - insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Baseline, month 6Population: The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned
The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors
Outcome measures
| Measure |
Ranibizumab
n=124 Participants
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=119 Participants
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Change Over Time in BCVA
Month 3
|
14.04 letters
Interval 10.92 to 17.16
|
4.99 letters
Interval 1.79 to 8.18
|
|
Change Over Time in BCVA
Month 4
|
12.76 letters
Interval 9.48 to 16.04
|
-1.73 letters
Interval -5.09 to 1.63
|
|
Change Over Time in BCVA
Month 5
|
13.57 letters
Interval 10.25 to 16.89
|
-2.92 letters
Interval -6.33 to 0.48
|
|
Change Over Time in BCVA
Month 6
|
14.78 letters
Interval 11.24 to 18.32
|
-3.17 letters
Interval -6.8 to 0.46
|
|
Change Over Time in BCVA
Month 1
|
9.77 letters
Interval 7.27 to 12.27
|
9.54 letters
Interval 6.98 to 12.1
|
|
Change Over Time in BCVA
Month 2
|
12.25 letters
Interval 9.59 to 14.91
|
11.04 letters
Interval 8.31 to 13.76
|
SECONDARY outcome
Timeframe: Baseline, month 6Population: The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned
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
n=122 Participants
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=119 Participants
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Change Over Time of the Central Retinal Thickness (CRT)
|
-376.7 µm
Standard Deviation 274.9
|
-168.7 µm
Standard Deviation 288.3
|
SECONDARY outcome
Timeframe: Baseline, month 6Population: The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned
The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function
Outcome measures
| Measure |
Ranibizumab
n=121 Participants
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=118 Participants
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires
|
6.0 Score on a scale
Standard Deviation 12.1
|
2.0 Score on a scale
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Baseline, month 6Population: The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. observed is only described in this analysis.
SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health
Outcome measures
| Measure |
Ranibizumab
n=116 Participants
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=113 Participants
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires
SF-36 physical component (n=116,113)
|
-0.7 Units on a scale
Standard Deviation 6.3
|
0.4 Units on a scale
Standard Deviation 6.6
|
|
Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires
SF-36 mental component (n=116,113)
|
2.4 Units on a scale
Standard Deviation 8.7
|
0.4 Units on a scale
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: Baseline, month 6Population: The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Observed participants are only described in this analysis
The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state.
Outcome measures
| Measure |
Ranibizumab
n=116 Participants
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=113 Participants
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires
|
0.1 Units on a scale
Standard Deviation 13.2
|
2.0 Units on a scale
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: Baseline, month 6Population: The Safety Set consisted of all patients from the RS who had received at least one application of study treatment and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no adverse events also constituted a safety assessment
The proportion of patients with ≥ 10% increase in Internal Ocular Pressure (IOP) compared to baseline at any post-baseline visit.
Outcome measures
| Measure |
Ranibizumab
n=124 Participants
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=119 Participants
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Increase Rate of the Internal Ocular Pressure (IOP ) : Patients With ≥10% Increase in IOP Compared to Baseline
|
94 Participants
|
105 Participants
|
Adverse Events
Ranibizumab
Dexamethasone
Serious adverse events
| Measure |
Ranibizumab
n=124 participants at risk
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=119 participants at risk
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/124
|
0.84%
1/119
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.81%
1/124
|
0.84%
1/119
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/124
|
0.84%
1/119
|
|
Cardiac disorders
MITRAL VALVE INCOMPETENCE
|
0.00%
0/124
|
0.84%
1/119
|
|
Congenital, familial and genetic disorders
ADENOMATOUS POLYPOSIS COLI
|
0.81%
1/124
|
0.00%
0/119
|
|
Ear and labyrinth disorders
DEAFNESS
|
0.00%
0/124
|
0.84%
1/119
|
|
Eye disorders
CONJUNCTIVAL HYPERAEMIA (Study eye)
|
0.00%
0/124
|
0.84%
1/119
|
|
Eye disorders
CORNEAL OEDEMA (Study eye)
|
0.00%
0/124
|
0.84%
1/119
|
|
Eye disorders
EYE PAIN (Study eye)
|
0.00%
0/124
|
0.84%
1/119
|
|
Eye disorders
GLAUCOMA (Study eye)
|
0.00%
0/124
|
2.5%
3/119
|
|
Eye disorders
HYPHAEMA (Study eye)
|
0.00%
0/124
|
2.5%
3/119
|
|
Eye disorders
IRIS NEOVASCULARISATION (Study eye)
|
0.00%
0/124
|
3.4%
4/119
|
|
Eye disorders
MACULAR OEDEMA (Study eye)
|
0.81%
1/124
|
1.7%
2/119
|
|
Eye disorders
RETINAL ARTERY OCCLUSION (Study eye)
|
0.00%
0/124
|
0.84%
1/119
|
|
Eye disorders
RETINAL VEIN OCCLUSION (Study eye)
|
0.81%
1/124
|
0.84%
1/119
|
|
Eye disorders
VISUAL ACUITY REDUCED (Study eye)
|
0.00%
0/124
|
2.5%
3/119
|
|
Eye disorders
VITREOUS HAEMORRHAGE (Study eye)
|
0.00%
0/124
|
0.84%
1/119
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA
|
0.00%
0/124
|
0.84%
1/119
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/124
|
0.84%
1/119
|
|
Gastrointestinal disorders
GASTRODUODENAL ULCER
|
0.81%
1/124
|
0.00%
0/119
|
|
Gastrointestinal disorders
OESOPHAGEAL RUPTURE
|
0.81%
1/124
|
0.00%
0/119
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.81%
1/124
|
0.00%
0/119
|
|
General disorders
ASTHENIA
|
0.81%
1/124
|
0.00%
0/119
|
|
General disorders
FATIGUE
|
0.81%
1/124
|
0.00%
0/119
|
|
Infections and infestations
CYSTITIS
|
0.81%
1/124
|
0.00%
0/119
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/124
|
0.84%
1/119
|
|
Infections and infestations
PNEUMONIA
|
0.81%
1/124
|
0.00%
0/119
|
|
Infections and infestations
SOFT TISSUE INFECTION
|
0.00%
0/124
|
0.84%
1/119
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.81%
1/124
|
0.00%
0/119
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.81%
1/124
|
0.00%
0/119
|
|
Investigations
INTRAOCULAR PRESSURE DECREASED (Study eye)
|
0.00%
0/124
|
0.84%
1/119
|
|
Investigations
INTRAOCULAR PRESSURE INCREASED (Study eye)
|
0.00%
0/124
|
0.84%
1/119
|
|
Investigations
PROSTATIC SPECIFIC ANTIGEN INCREASED
|
0.81%
1/124
|
0.00%
0/119
|
|
Investigations
WEIGHT DECREASED
|
0.81%
1/124
|
0.00%
0/119
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/124
|
0.84%
1/119
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA OF COLON
|
0.00%
0/124
|
0.84%
1/119
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTROINTESTINAL CARCINOMA
|
0.00%
0/124
|
0.84%
1/119
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL NEOPLASM
|
0.00%
0/124
|
0.84%
1/119
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/124
|
0.84%
1/119
|
|
Nervous system disorders
RADIAL NERVE PALSY
|
0.00%
0/124
|
0.84%
1/119
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/124
|
1.7%
2/119
|
|
Reproductive system and breast disorders
PROSTATITIS
|
0.81%
1/124
|
0.00%
0/119
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/124
|
0.84%
1/119
|
Other adverse events
| Measure |
Ranibizumab
n=124 participants at risk
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
|
Dexamethasone
n=119 participants at risk
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
|
|---|---|---|
|
Eye disorders
ABNORMAL SENSATION IN EYE (Study eye)
|
4.8%
6/124
|
6.7%
8/119
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE (Study eye)
|
12.9%
16/124
|
10.9%
13/119
|
|
Eye disorders
DRY EYE (Fellow eye)
|
3.2%
4/124
|
0.84%
1/119
|
|
Eye disorders
DRY EYE (Study eye)
|
3.2%
4/124
|
3.4%
4/119
|
|
Eye disorders
EYE IRRITATION (Study eye)
|
3.2%
4/124
|
2.5%
3/119
|
|
Eye disorders
EYE PAIN (Study eye)
|
12.1%
15/124
|
11.8%
14/119
|
|
Eye disorders
FOREIGN BODY SENSATION IN EYES (Study eye)
|
4.8%
6/124
|
5.0%
6/119
|
|
Eye disorders
GLAUCOMA (Study eye)
|
0.00%
0/124
|
4.2%
5/119
|
|
Eye disorders
IRIS NEOVASCULARISATION (Study eye)
|
0.00%
0/124
|
4.2%
5/119
|
|
Eye disorders
LACRIMATION INCREASED (Study eye)
|
4.8%
6/124
|
6.7%
8/119
|
|
Eye disorders
MACULAR ISCHAEMIA (Study eye)
|
0.00%
0/124
|
2.5%
3/119
|
|
Eye disorders
MACULAR OEDEMA (Study eye)
|
10.5%
13/124
|
16.0%
19/119
|
|
Eye disorders
OCULAR HYPERAEMIA (Study eye)
|
11.3%
14/124
|
12.6%
15/119
|
|
Eye disorders
OCULAR HYPERTENSION (Study eye)
|
0.00%
0/124
|
5.0%
6/119
|
|
Eye disorders
OPTIC DISC VASCULAR DISORDER (Study eye)
|
4.0%
5/124
|
0.00%
0/119
|
|
Eye disorders
RETINAL EXUDATES (Study eye)
|
1.6%
2/124
|
3.4%
4/119
|
|
Eye disorders
RETINAL ISCHAEMIA (Study eye)
|
0.81%
1/124
|
5.0%
6/119
|
|
Eye disorders
RETINAL VASCULAR DISORDER (Study eye)
|
1.6%
2/124
|
4.2%
5/119
|
|
Eye disorders
VISUAL ACUITY REDUCED (Study eye)
|
6.5%
8/124
|
16.0%
19/119
|
|
Eye disorders
VISUAL IMPAIRMENT (Study eye)
|
1.6%
2/124
|
5.0%
6/119
|
|
Eye disorders
VITREOUS DETACHMENT (Study eye)
|
4.0%
5/124
|
2.5%
3/119
|
|
Eye disorders
VITREOUS FLOATERS (Study eye)
|
4.0%
5/124
|
9.2%
11/119
|
|
Gastrointestinal disorders
DIARRHOEA
|
4.8%
6/124
|
1.7%
2/119
|
|
Gastrointestinal disorders
NAUSEA
|
3.2%
4/124
|
2.5%
3/119
|
|
General disorders
PYREXIA
|
0.00%
0/124
|
2.5%
3/119
|
|
Infections and infestations
BRONCHITIS
|
0.81%
1/124
|
2.5%
3/119
|
|
Infections and infestations
NASOPHARYNGITIS
|
7.3%
9/124
|
10.1%
12/119
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.81%
1/124
|
3.4%
4/119
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
3.2%
4/124
|
1.7%
2/119
|
|
Investigations
INTRAOCULAR PRESSURE INCREASED (Fellow eye)
|
0.00%
0/124
|
2.5%
3/119
|
|
Investigations
INTRAOCULAR PRESSURE INCREASED (Study eye)
|
5.6%
7/124
|
31.9%
38/119
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
1.6%
2/124
|
2.5%
3/119
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
5.6%
7/124
|
3.4%
4/119
|
|
Nervous system disorders
HEADACHE
|
5.6%
7/124
|
8.4%
10/119
|
|
Vascular disorders
HYPERTENSION
|
4.0%
5/124
|
2.5%
3/119
|
|
Vascular disorders
VASCULAR SHUNT (Study eye)
|
0.81%
1/124
|
2.5%
3/119
|
Additional Information
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