Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001020-38 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab | Experimental |
| |
| Standard of Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug |
| ||
| Dexamethasone implant and sham injections |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Average BCVA Change From Month 1 Through Month 6 to Baseline | 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 | Baseline, month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean BCVA Change at 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 | Baseline, month 6 |
| Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Leipzig | Germany | 04103 | Germany | ||
| Novartis Investigative Site |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally |
| FG001 | Dexamethasone | Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
| Baseline, 6 month |
| Time to Achieve a Significant Improvement ≥ 15 Letters | The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts | Baseline, month 6 |
| Change Over Time in BCVA | 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 | Baseline, month 6 |
| Change Over Time of the Central Retinal Thickness (CRT) | Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation | Baseline, month 6 |
| Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires | 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 | Baseline, month 6 |
| Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires | SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health | Baseline, month 6 |
| Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires | The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state. | Baseline, month 6 |
| Increase Rate of the Internal Ocular Pressure (IOP ) : Patients With ≥10% Increase in IOP Compared to Baseline | The proportion of patients with ≥ 10% increase in Internal Ocular Pressure (IOP) compared to baseline at any post-baseline visit. | Baseline, month 6 |
| Regensburg |
| Germany |
| 93042 |
| Germany |
| Novartis Investigative Site | Augsburg | 85155 | Germany |
| Novartis Investigative Site | Bad Rothenfelde | 49215 | Germany |
| Novartis Investigative Site | Berlin | 10713 | Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Bonn | 53127 | Germany |
| Novartis Investigative Site | Bremen | 28209 | Germany |
| Novartis Investigative Site | Chemnitz | 09116 | Germany |
| Novartis Investigative Site | Cologne | 50935 | Germany |
| Novartis Investigative Site | Darmstadt | 64298 | Germany |
| Novartis Investigative Site | Dortmund | 44137 | Germany |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Düsseldorf | 40225 | Germany |
| Novartis Investigative Site | Frankfurt | 60318 | Germany |
| Novartis Investigative Site | Freiburg I. Br | 79106 | Germany |
| Novartis Investigative Site | Glauchau | 08371 | Germany |
| Novartis Investigative Site | Göttingen | 37075 | Germany |
| Novartis Investigative Site | Hagen | 58097 | Germany |
| Novartis Investigative Site | Hamburg | 20246 | Germany |
| Novartis Investigative Site | Hamburg | 22417 | Germany |
| Novartis Investigative Site | Homburg | 66421 | Germany |
| Novartis Investigative Site | Ingolstadt | 85049 | Germany |
| Novartis Investigative Site | Karlsruhe | 76133 | Germany |
| Novartis Investigative Site | Karlsruhe | 76199 | Germany |
| Novartis Investigative Site | Kiel | 24105 | Germany |
| Novartis Investigative Site | Lauterbach | 36341 | Germany |
| Novartis Investigative Site | Ludwigshafen | 67063 | Germany |
| Novartis Investigative Site | Minden | 32427 | Germany |
| Novartis Investigative Site | Mülheim | 45468 | Germany |
| Novartis Investigative Site | München | 80336 | Germany |
| Novartis Investigative Site | München | 81675 | Germany |
| Novartis Investigative Site | Münster | 48145 | Germany |
| Novartis Investigative Site | Münster | 48149 | Germany |
| Novartis Investigative Site | Nuremberg | 90491 | Germany |
| Novartis Investigative Site | Recklinghausen | 45657 | Germany |
| Novartis Investigative Site | Sulzbach | 66280 | Germany |
| Novartis Investigative Site | Tübingen | 72076 | Germany |
| Novartis Investigative Site | Ulm | 89075 | Germany |
| Novartis Investigative Site | Wolfsburg | 38442 | Germany |
| Novartis Investigative Site | Würzburg | 97080 | Germany |
| Novartis Investigative Site | Budapest | 1083 | Hungary |
| Novartis Investigative Site | Budapest | 1133 | Hungary |
| Novartis Investigative Site | Szeged | H-6720 | Hungary |
| Novartis Investigative Site | Bydgoszcz | Poland |
| Novartis Investigative Site | Bytom | 41-902 | Poland |
| Novartis Investigative Site | Birmingham | B152WB | United Kingdom |
| Novartis Investigative Site | Birmingham | B18 7QU | United Kingdom |
| Novartis Investigative Site | Bradford | BD9 6RJ | United Kingdom |
| Novartis Investigative Site | Cheshire | CW1 4QJ | United Kingdom |
| Novartis Investigative Site | Colchester | CO3 3NB | United Kingdom |
| Novartis Investigative Site | Derby | DE22 3NE | United Kingdom |
| Novartis Investigative Site | Gloucester | GL1 3NN | United Kingdom |
| Novartis Investigative Site | Guildford, Surrey | GU2 5XX | United Kingdom |
| Novartis Investigative Site | Kent | CT1 3NG | United Kingdom |
| Novartis Investigative Site | Leeds | LS9 7TF | United Kingdom |
| Novartis Investigative Site | London | SE1 7EH | United Kingdom |
| Novartis Investigative Site | Manchester | M13 9WH | United Kingdom |
| Novartis Investigative Site | Middlesbrough | TS4 3BW | United Kingdom |
| Novartis Investigative Site | Nottingham | NG7 2UH | United Kingdom |
| Novartis Investigative Site | Portsmouth | PO6 3LY | United Kingdom |
| Novartis Investigative Site | Rugby | CV22 5PX | United Kingdom |
| Novartis Investigative Site | Westcliff-on-Sea | SS0 0RY | United Kingdom |
| Novartis Investigative Site | York | YO31 8HE | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally |
| BG001 | Dexamethasone | Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Average BCVA Change From Month 1 Through Month 6 to Baseline | 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 | 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 | Posted | Mean | Standard Deviation | Letters | Baseline, month 6 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Mean BCVA Change at 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 | 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 | Posted | Least Squares Mean | 95% Confidence Interval | Letters | Baseline, month 6 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters | 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 | 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 | Posted | Number | Participants | Baseline, 6 month |
|
| ||||||||||||||||||||||||||||||
| Secondary | Time to Achieve a Significant Improvement ≥ 15 Letters | The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts | 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 | Posted | Median | 95% Confidence Interval | Time to event (Days) | Baseline, month 6 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change Over Time in BCVA | 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 | 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 | Posted | Least Squares Mean | 95% Confidence Interval | letters | Baseline, month 6 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change Over Time of the Central Retinal Thickness (CRT) | Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation | 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 | Posted | Mean | Standard Deviation | µm | Baseline, month 6 |
|
| |||||||||||||||||||||||||||||
| Secondary | Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires | 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 | 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 | Posted | Mean | Standard Deviation | Score on a scale | Baseline, month 6 |
| ||||||||||||||||||||||||||||||
| Secondary | Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires | SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, month 6 |
|
| |||||||||||||||||||||||||||||
| Secondary | Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires | The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state. | 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 | Posted | Mean | Standard Deviation | Units on a scale | Baseline, month 6 |
|
| |||||||||||||||||||||||||||||
| Secondary | Increase Rate of the Internal Ocular Pressure (IOP ) : Patients With ≥10% Increase in IOP Compared to Baseline | The proportion of patients with ≥ 10% increase in Internal Ocular Pressure (IOP) compared to baseline at any post-baseline visit. | 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 | Posted | Number | Participants | Baseline, month 6 |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ranibizumab | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally | 10 | 124 | 77 | 124 | ||
| EG001 | Dexamethasone | Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months | 16 | 119 | 99 | 119 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANGINA PECTORIS | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| MITRAL VALVE INCOMPETENCE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| ADENOMATOUS POLYPOSIS COLI | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| DEAFNESS | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| CONJUNCTIVAL HYPERAEMIA (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| CORNEAL OEDEMA (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| EYE PAIN (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| GLAUCOMA (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| HYPHAEMA (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| IRIS NEOVASCULARISATION (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| MACULAR OEDEMA (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| RETINAL ARTERY OCCLUSION (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| RETINAL VEIN OCCLUSION (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| VISUAL ACUITY REDUCED (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| VITREOUS HAEMORRHAGE (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| ABDOMINAL HERNIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| GASTRODUODENAL ULCER | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| OESOPHAGEAL RUPTURE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| UMBILICAL HERNIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| SOFT TISSUE INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| WRIST FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| INTRAOCULAR PRESSURE DECREASED (Study eye) | Investigations | MedDRA | Systematic Assessment |
| |
| INTRAOCULAR PRESSURE INCREASED (Study eye) | Investigations | MedDRA | Systematic Assessment |
| |
| PROSTATIC SPECIFIC ANTIGEN INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| ADENOCARCINOMA OF COLON | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| GASTROINTESTINAL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| RENAL NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| RADIAL NERVE PALSY | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| PROSTATITIS | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABNORMAL SENSATION IN EYE (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| CONJUNCTIVAL HAEMORRHAGE (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| DRY EYE (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| DRY EYE (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| EYE IRRITATION (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| EYE PAIN (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| FOREIGN BODY SENSATION IN EYES (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| GLAUCOMA (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| IRIS NEOVASCULARISATION (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| LACRIMATION INCREASED (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| MACULAR ISCHAEMIA (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| MACULAR OEDEMA (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| OCULAR HYPERAEMIA (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| OCULAR HYPERTENSION (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| OPTIC DISC VASCULAR DISORDER (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| RETINAL EXUDATES (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| RETINAL ISCHAEMIA (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| RETINAL VASCULAR DISORDER (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| VISUAL ACUITY REDUCED (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| VISUAL IMPAIRMENT (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| VITREOUS DETACHMENT (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| VITREOUS FLOATERS (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| BLOOD GLUCOSE INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| INTRAOCULAR PRESSURE INCREASED (Fellow eye) | Investigations | MedDRA | Systematic Assessment |
| |
| INTRAOCULAR PRESSURE INCREASED (Study eye) | Investigations | MedDRA | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA | Systematic Assessment |
| |
| VASCULAR SHUNT (Study eye) | Vascular disorders | MedDRA | Systematic Assessment |
|
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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | trialandresults.registries@novartis.com |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D008269 | Macular Edema |
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Male |
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|