COMRADE-C: Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Central Retinal Vein Occlusion (CRVO)
Study Details
Study Description
Brief Summary
This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant® after 6 months of treatment. In the study arm Lucentis will be given monthly in a pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with sham injections PRN afterwards.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Ranibizumab
|
Drug: Ranibizumab
|
Active Comparator: Standard of Care
|
Drug: Dexamethasone implant and sham injections
|
Outcome Measures
Primary Outcome Measures
- Mean Average BCVA Change From Month 1 Through Month 6 to Baseline [Baseline, month 6]
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
Secondary Outcome Measures
- Mean BCVA Change at Month 6 [Baseline, month 6]
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
- Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters [Baseline, 6 month]
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
- Time to Achieve a Significant Improvement ≥ 15 Letters [Baseline, month 6]
The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts
- Change Over Time in BCVA [Baseline, month 6]
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
- Change Over Time of the Central Retinal Thickness (CRT) [Baseline, month 6]
Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation
- Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires [Baseline, month 6]
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
- Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires [Baseline, month 6]
SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health
- Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires [Baseline, month 6]
The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state.
- Increase Rate of the Internal Ocular Pressure (IOP ) : Patients With ≥10% Increase in IOP Compared to Baseline [Baseline, month 6]
The proportion of patients with ≥ 10% increase in Internal Ocular Pressure (IOP) compared to baseline at any post-baseline visit.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients diagnosed with visual impairment due to macular edema following CRVO
-
Diagnosis of CRVO at maximum 6 months prior to Screening
-
BCVA using ETDRS charts of 20/40 to 20/400 in the study eye
Exclusion Criteria:
-
Media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs
-
Central retinal thickness (CRT) < 250 µm in the study eye
-
Prior episode of RVO in the study eye
-
Active formation of new vessels in the study eye
-
Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline
-
IOP ≥ 30mmHg or uncontrolled glaucoma; patients may be re-screened after 1 month if they have undergone glaucoma treatment
-
Improvement of > 10 letters on BCVA between Screening and Baseline
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Novartis Investigative Site | Augsburg | Germany | 85155 | |
2 | Novartis Investigative Site | Bad Rothenfelde | Germany | 49215 | |
3 | Novartis Investigative Site | Berlin | Germany | 10713 | |
4 | Novartis Investigative Site | Berlin | Germany | 13353 | |
5 | Novartis Investigative Site | Bonn | Germany | 53127 | |
6 | Novartis Investigative Site | Bremen | Germany | 28209 | |
7 | Novartis Investigative Site | Chemnitz | Germany | 09116 | |
8 | Novartis Investigative Site | Darmstadt | Germany | 64298 | |
9 | Novartis Investigative Site | Dortmund | Germany | 44137 | |
10 | Novartis Investigative Site | Dresden | Germany | 01307 | |
11 | Novartis Investigative Site | Duesseldorf | Germany | 40225 | |
12 | Novartis Investigative Site | Frankfurt | Germany | 60318 | |
13 | Novartis Investigative Site | Freiburg i. Br | Germany | 79106 | |
14 | Novartis Investigative Site | Glauchau | Germany | 08371 | |
15 | Novartis Investigative Site | Göttingen | Germany | 37075 | |
16 | Novartis Investigative Site | Hagen | Germany | 58097 | |
17 | Novartis Investigative Site | Hamburg | Germany | 20246 | |
18 | Novartis Investigative Site | Hamburg | Germany | 22417 | |
19 | Novartis Investigative Site | Homburg | Germany | 66421 | |
20 | Novartis Investigative Site | Ingolstadt | Germany | 85049 | |
21 | Novartis Investigative Site | Karlsruhe | Germany | 76133 | |
22 | Novartis Investigative Site | Karlsruhe | Germany | 76199 | |
23 | Novartis Investigative Site | Kiel | Germany | 24105 | |
24 | Novartis Investigative Site | Koeln | Germany | 50935 | |
25 | Novartis Investigative Site | Lauterbach | Germany | 36341 | |
26 | Novartis Investigative Site | Leipzig | Germany | 04103 | |
27 | Novartis Investigative Site | Ludwigshafen | Germany | 67063 | |
28 | Novartis Investigative Site | Minden | Germany | 32427 | |
29 | Novartis Investigative Site | Muelheim | Germany | 45468 | |
30 | Novartis Investigative Site | Muenster | Germany | 48145 | |
31 | Novartis Investigative Site | Muenster | Germany | 48149 | |
32 | Novartis Investigative Site | München | Germany | 80336 | |
33 | Novartis Investigative Site | München | Germany | 81675 | |
34 | Novartis Investigative Site | Nuernberg | Germany | 90491 | |
35 | Novartis Investigative Site | Recklinghausen | Germany | 45657 | |
36 | Novartis Investigative Site | Regensburg | Germany | 93042 | |
37 | Novartis Investigative Site | Sulzbach | Germany | 66280 | |
38 | Novartis Investigative Site | Tübingen | Germany | 72076 | |
39 | Novartis Investigative Site | Ulm | Germany | 89075 | |
40 | Novartis Investigative Site | Wolfsburg | Germany | 38442 | |
41 | Novartis Investigative Site | Würzburg | Germany | 97080 | |
42 | Novartis Investigative Site | Budapest | Hungary | 1083 | |
43 | Novartis Investigative Site | Budapest | Hungary | 1133 | |
44 | Novartis Investigative Site | Szeged | Hungary | H-6720 | |
45 | Novartis Investigative Site | Bydgoszcz | Poland | ||
46 | Novartis Investigative Site | Bytom | Poland | 41-902 | |
47 | Novartis Investigative Site | Birmingham | United Kingdom | B152WB | |
48 | Novartis Investigative Site | Birmingham | United Kingdom | B18 7QU | |
49 | Novartis Investigative Site | Bradford | United Kingdom | BD9 6RJ | |
50 | Novartis Investigative Site | Cheshire | United Kingdom | CW1 4QJ | |
51 | Novartis Investigative Site | Colchester | United Kingdom | CO3 3NB | |
52 | Novartis Investigative Site | Derby | United Kingdom | DE22 3NE | |
53 | Novartis Investigative Site | Gloucester | United Kingdom | GL1 3NN | |
54 | Novartis Investigative Site | Guildford, Surrey | United Kingdom | GU2 5XX | |
55 | Novartis Investigative Site | Kent | United Kingdom | CT1 3NG | |
56 | Novartis Investigative Site | Leeds | United Kingdom | LS9 7TF | |
57 | Novartis Investigative Site | London | United Kingdom | SE1 7EH | |
58 | Novartis Investigative Site | Manchester | United Kingdom | M13 9WH | |
59 | Novartis Investigative Site | Middlesborough | United Kingdom | TS4 3BW | |
60 | Novartis Investigative Site | Nottingham | United Kingdom | NG7 2UH | |
61 | Novartis Investigative Site | Portsmouth | United Kingdom | PO6 3LY | |
62 | Novartis Investigative Site | Rugby | United Kingdom | CV22 5PX | |
63 | Novartis Investigative Site | Westcliff-on-Sea | United Kingdom | SS0 0RY | |
64 | Novartis Investigative Site | York | United Kingdom | YO31 8HE |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRFB002EDE18
- 2011-001020-38
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Ranibizumab | Dexamethasone |
---|---|---|
Arm/Group Description | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally | Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months |
Period Title: Overall Study | ||
STARTED | 124 | 119 |
COMPLETED | 113 | 72 |
NOT COMPLETED | 11 | 47 |
Baseline Characteristics
Arm/Group Title | Ranibizumab | Dexamethasone | Total |
---|---|---|---|
Arm/Group Description | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally | Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months | Total of all reporting groups |
Overall Participants | 124 | 119 | 243 |
Age (Years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [Years] |
65.3
(11.4)
|
66.9
(12.4)
|
66.1
(11.9)
|
Sex: Female, Male (Count of Participants) | |||
Female |
52
41.9%
|
46
38.7%
|
98
40.3%
|
Male |
72
58.1%
|
73
61.3%
|
145
59.7%
|
Outcome Measures
Title | Mean Average BCVA Change From Month 1 Through Month 6 to Baseline |
---|---|
Description | 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 |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | Ranibizumab | Dexamethasone |
---|---|---|
Arm/Group Description | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally | Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months |
Measure Participants | 124 | 119 |
Mean (Standard Deviation) [Letters] |
14.6
(11.8)
|
4.8
(16.2)
|
Title | Mean BCVA Change at Month 6 |
---|---|
Description | 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 |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | Ranibizumab | Dexamethasone |
---|---|---|
Arm/Group Description | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally | Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months |
Measure Participants | 124 | 119 |
Least Squares Mean (95% Confidence Interval) [Letters] |
14.78
|
-3.17
|
Title | Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters |
---|---|
Description | 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 |
Time Frame | Baseline, 6 month |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | Ranibizumab | Dexamethasone |
---|---|---|
Arm/Group Description | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally | Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months |
Measure Participants | 124 | 119 |
Gain≥15 letters |
73
58.9%
|
22
18.5%
|
Loss of ≥15 letters |
1
0.8%
|
31
26.1%
|
Gain ≥10 letters |
89
71.8%
|
38
31.9%
|
Loss of ≥10 letters |
4
3.2%
|
35
29.4%
|
Gain ≥5 letters |
104
83.9%
|
54
45.4%
|
Loss of ≥5 letters |
5
4%
|
40
33.6%
|
Title | Time to Achieve a Significant Improvement ≥ 15 Letters |
---|---|
Description | The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | Ranibizumab | Dexamethasone |
---|---|---|
Arm/Group Description | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally | Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months |
Measure Participants | 124 | 119 |
Median (95% Confidence Interval) [Time to event (Days)] |
62
|
98
|
Title | Change Over Time in BCVA |
---|---|
Description | 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 |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | Ranibizumab | Dexamethasone |
---|---|---|
Arm/Group Description | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally | Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months |
Measure Participants | 124 | 119 |
Month 1 |
9.77
|
9.54
|
Month 2 |
12.25
|
11.04
|
Month 3 |
14.04
|
4.99
|
Month 4 |
12.76
|
-1.73
|
Month 5 |
13.57
|
-2.92
|
Month 6 |
14.78
|
-3.17
|
Title | Change Over Time of the Central Retinal Thickness (CRT) |
---|---|
Description | Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | Ranibizumab | Dexamethasone |
---|---|---|
Arm/Group Description | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally | Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months |
Measure Participants | 122 | 119 |
Mean (Standard Deviation) [µm] |
-376.7
(274.9)
|
-168.7
(288.3)
|
Title | Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires |
---|---|
Description | 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 |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | Ranibizumab | Dexamethasone |
---|---|---|
Arm/Group Description | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally | Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months |
Measure Participants | 121 | 118 |
Mean (Standard Deviation) [Score on a scale] |
6.0
(12.1)
|
2.0
(10.9)
|
Title | Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires |
---|---|
Description | SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Ranibizumab | Dexamethasone |
---|---|---|
Arm/Group Description | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally | Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months |
Measure Participants | 116 | 113 |
SF-36 physical component (n=116,113) |
-0.7
(6.3)
|
0.4
(6.6)
|
SF-36 mental component (n=116,113) |
2.4
(8.7)
|
0.4
(9.2)
|
Title | Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires |
---|---|
Description | The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state. |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | Ranibizumab | Dexamethasone |
---|---|---|
Arm/Group Description | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally | Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months |
Measure Participants | 116 | 113 |
Mean (Standard Deviation) [Units on a scale] |
0.1
(13.2)
|
2.0
(14.8)
|
Title | Increase Rate of the Internal Ocular Pressure (IOP ) : Patients With ≥10% Increase in IOP Compared to Baseline |
---|---|
Description | The proportion of patients with ≥ 10% increase in Internal Ocular Pressure (IOP) compared to baseline at any post-baseline visit. |
Time Frame | Baseline, month 6 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | Ranibizumab | Dexamethasone |
---|---|---|
Arm/Group Description | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally | Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months |
Measure Participants | 124 | 119 |
Number [Participants] |
94
75.8%
|
105
88.2%
|
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Ranibizumab | Dexamethasone | ||
Arm/Group Description | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally | Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months | ||
All Cause Mortality |
||||
Ranibizumab | Dexamethasone | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Ranibizumab | Dexamethasone | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 10/124 (8.1%) | 16/119 (13.4%) | ||
Cardiac disorders | ||||
ANGINA PECTORIS | 0/124 (0%) | 1/119 (0.8%) | ||
ATRIAL FIBRILLATION | 1/124 (0.8%) | 1/119 (0.8%) | ||
CARDIAC FAILURE | 0/124 (0%) | 1/119 (0.8%) | ||
MITRAL VALVE INCOMPETENCE | 0/124 (0%) | 1/119 (0.8%) | ||
Congenital, familial and genetic disorders | ||||
ADENOMATOUS POLYPOSIS COLI | 1/124 (0.8%) | 0/119 (0%) | ||
Ear and labyrinth disorders | ||||
DEAFNESS | 0/124 (0%) | 1/119 (0.8%) | ||
Eye disorders | ||||
CONJUNCTIVAL HYPERAEMIA (Study eye) | 0/124 (0%) | 1/119 (0.8%) | ||
CORNEAL OEDEMA (Study eye) | 0/124 (0%) | 1/119 (0.8%) | ||
EYE PAIN (Study eye) | 0/124 (0%) | 1/119 (0.8%) | ||
GLAUCOMA (Study eye) | 0/124 (0%) | 3/119 (2.5%) | ||
HYPHAEMA (Study eye) | 0/124 (0%) | 3/119 (2.5%) | ||
IRIS NEOVASCULARISATION (Study eye) | 0/124 (0%) | 4/119 (3.4%) | ||
MACULAR OEDEMA (Study eye) | 1/124 (0.8%) | 2/119 (1.7%) | ||
RETINAL ARTERY OCCLUSION (Study eye) | 0/124 (0%) | 1/119 (0.8%) | ||
RETINAL VEIN OCCLUSION (Study eye) | 1/124 (0.8%) | 1/119 (0.8%) | ||
VISUAL ACUITY REDUCED (Study eye) | 0/124 (0%) | 3/119 (2.5%) | ||
VITREOUS HAEMORRHAGE (Study eye) | 0/124 (0%) | 1/119 (0.8%) | ||
Gastrointestinal disorders | ||||
ABDOMINAL HERNIA | 0/124 (0%) | 1/119 (0.8%) | ||
COLITIS | 0/124 (0%) | 1/119 (0.8%) | ||
GASTRODUODENAL ULCER | 1/124 (0.8%) | 0/119 (0%) | ||
OESOPHAGEAL RUPTURE | 1/124 (0.8%) | 0/119 (0%) | ||
UMBILICAL HERNIA | 1/124 (0.8%) | 0/119 (0%) | ||
General disorders | ||||
ASTHENIA | 1/124 (0.8%) | 0/119 (0%) | ||
FATIGUE | 1/124 (0.8%) | 0/119 (0%) | ||
Infections and infestations | ||||
CYSTITIS | 1/124 (0.8%) | 0/119 (0%) | ||
DIVERTICULITIS | 0/124 (0%) | 1/119 (0.8%) | ||
PNEUMONIA | 1/124 (0.8%) | 0/119 (0%) | ||
SOFT TISSUE INFECTION | 0/124 (0%) | 1/119 (0.8%) | ||
Injury, poisoning and procedural complications | ||||
UPPER LIMB FRACTURE | 1/124 (0.8%) | 0/119 (0%) | ||
WRIST FRACTURE | 1/124 (0.8%) | 0/119 (0%) | ||
Investigations | ||||
INTRAOCULAR PRESSURE DECREASED (Study eye) | 0/124 (0%) | 1/119 (0.8%) | ||
INTRAOCULAR PRESSURE INCREASED (Study eye) | 0/124 (0%) | 1/119 (0.8%) | ||
PROSTATIC SPECIFIC ANTIGEN INCREASED | 1/124 (0.8%) | 0/119 (0%) | ||
WEIGHT DECREASED | 1/124 (0.8%) | 0/119 (0%) | ||
Musculoskeletal and connective tissue disorders | ||||
BACK PAIN | 0/124 (0%) | 1/119 (0.8%) | ||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
ADENOCARCINOMA OF COLON | 0/124 (0%) | 1/119 (0.8%) | ||
GASTROINTESTINAL CARCINOMA | 0/124 (0%) | 1/119 (0.8%) | ||
RENAL NEOPLASM | 0/124 (0%) | 1/119 (0.8%) | ||
Nervous system disorders | ||||
HEADACHE | 0/124 (0%) | 1/119 (0.8%) | ||
RADIAL NERVE PALSY | 0/124 (0%) | 1/119 (0.8%) | ||
TRANSIENT ISCHAEMIC ATTACK | 0/124 (0%) | 2/119 (1.7%) | ||
Reproductive system and breast disorders | ||||
PROSTATITIS | 1/124 (0.8%) | 0/119 (0%) | ||
Vascular disorders | ||||
HYPERTENSION | 0/124 (0%) | 1/119 (0.8%) | ||
Other (Not Including Serious) Adverse Events |
||||
Ranibizumab | Dexamethasone | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 77/124 (62.1%) | 99/119 (83.2%) | ||
Eye disorders | ||||
ABNORMAL SENSATION IN EYE (Study eye) | 6/124 (4.8%) | 8/119 (6.7%) | ||
CONJUNCTIVAL HAEMORRHAGE (Study eye) | 16/124 (12.9%) | 13/119 (10.9%) | ||
DRY EYE (Fellow eye) | 4/124 (3.2%) | 1/119 (0.8%) | ||
DRY EYE (Study eye) | 4/124 (3.2%) | 4/119 (3.4%) | ||
EYE IRRITATION (Study eye) | 4/124 (3.2%) | 3/119 (2.5%) | ||
EYE PAIN (Study eye) | 15/124 (12.1%) | 14/119 (11.8%) | ||
FOREIGN BODY SENSATION IN EYES (Study eye) | 6/124 (4.8%) | 6/119 (5%) | ||
GLAUCOMA (Study eye) | 0/124 (0%) | 5/119 (4.2%) | ||
IRIS NEOVASCULARISATION (Study eye) | 0/124 (0%) | 5/119 (4.2%) | ||
LACRIMATION INCREASED (Study eye) | 6/124 (4.8%) | 8/119 (6.7%) | ||
MACULAR ISCHAEMIA (Study eye) | 0/124 (0%) | 3/119 (2.5%) | ||
MACULAR OEDEMA (Study eye) | 13/124 (10.5%) | 19/119 (16%) | ||
OCULAR HYPERAEMIA (Study eye) | 14/124 (11.3%) | 15/119 (12.6%) | ||
OCULAR HYPERTENSION (Study eye) | 0/124 (0%) | 6/119 (5%) | ||
OPTIC DISC VASCULAR DISORDER (Study eye) | 5/124 (4%) | 0/119 (0%) | ||
RETINAL EXUDATES (Study eye) | 2/124 (1.6%) | 4/119 (3.4%) | ||
RETINAL ISCHAEMIA (Study eye) | 1/124 (0.8%) | 6/119 (5%) | ||
RETINAL VASCULAR DISORDER (Study eye) | 2/124 (1.6%) | 5/119 (4.2%) | ||
VISUAL ACUITY REDUCED (Study eye) | 8/124 (6.5%) | 19/119 (16%) | ||
VISUAL IMPAIRMENT (Study eye) | 2/124 (1.6%) | 6/119 (5%) | ||
VITREOUS DETACHMENT (Study eye) | 5/124 (4%) | 3/119 (2.5%) | ||
VITREOUS FLOATERS (Study eye) | 5/124 (4%) | 11/119 (9.2%) | ||
Gastrointestinal disorders | ||||
DIARRHOEA | 6/124 (4.8%) | 2/119 (1.7%) | ||
NAUSEA | 4/124 (3.2%) | 3/119 (2.5%) | ||
General disorders | ||||
PYREXIA | 0/124 (0%) | 3/119 (2.5%) | ||
Infections and infestations | ||||
BRONCHITIS | 1/124 (0.8%) | 3/119 (2.5%) | ||
NASOPHARYNGITIS | 9/124 (7.3%) | 12/119 (10.1%) | ||
URINARY TRACT INFECTION | 1/124 (0.8%) | 4/119 (3.4%) | ||
Investigations | ||||
BLOOD GLUCOSE INCREASED | 4/124 (3.2%) | 2/119 (1.7%) | ||
INTRAOCULAR PRESSURE INCREASED (Fellow eye) | 0/124 (0%) | 3/119 (2.5%) | ||
INTRAOCULAR PRESSURE INCREASED (Study eye) | 7/124 (5.6%) | 38/119 (31.9%) | ||
Musculoskeletal and connective tissue disorders | ||||
ARTHRALGIA | 2/124 (1.6%) | 3/119 (2.5%) | ||
BACK PAIN | 7/124 (5.6%) | 4/119 (3.4%) | ||
Nervous system disorders | ||||
HEADACHE | 7/124 (5.6%) | 10/119 (8.4%) | ||
Vascular disorders | ||||
HYPERTENSION | 5/124 (4%) | 3/119 (2.5%) | ||
VASCULAR SHUNT (Study eye) | 1/124 (0.8%) | 3/119 (2.5%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
Results Point of Contact
Name/Title | Study Director |
---|---|
Organization | Novartis Pharmaceuticals |
Phone | 862-778-8300 |
trialandresults.registries@novartis.com |
- CRFB002EDE18
- 2011-001020-38