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Provide efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to CRVO
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab 0.5 mg | Experimental | PRN intravitreal injection |
|
| Sham injection | Sham Comparator | As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham injection | Other | Sham injections referred to the imitation of an intravitreal injection using an injection syringe without needle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3 | Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 3 and compared to Baseline. | Baseline, 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Average Change of Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 12 | Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline | Baseline, 12 months |
Not provided
Inclusion Criteria for study and fellow eye:
• Patients with visual impairment secondary to central retinal vein occlusion (CRVO) with a BCVA between 24 and 73 letters in one eye and at least 35 letters in the other eye.
Exclusion Criteria:
Pregnant or nursing women or women of child bearing potential unless using an effective contraception
- Stroke or myocard infarction within 3 months prior to study
History of malignancy within the past 5 years
Uncontrolled hypertension
Active infection or inflammation in any eye
use of corticosteroids for at least 30 days in the last 6 months
treatment with anti-angiogenic drugs in any eye within last 3 months
Panretinal or focal/drid laser photocoagulation within the last 3 and 4 months respectively
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Beijing | Beijing Municipality | 100191 | China | ||
| Novartis Investigative Site |
This study consisted of the 3 periods (Screening period: Day -14 to Day -1; treatment period:
Day 1 to Month 11; post-treatment period: Month 11 to Month 12). At Baseline (Visit 2, Day 1), eligible patients were randomized in a 3:1 ratio to one of the treatment arms
A total of 253 patients were randomized to this study, 191 patients to the ranibizumab group and 62 patients to the sham group. One patient randomized to the ranibizumab group was excluded from all analyses as informed consent was obtained after first study procedures were performed. Therefore, this patient not included in randomized set.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab 0.5 mg | PRN intravitreal injection |
| FG001 | Sham Injection | As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Ranibizumab 0.5 mg | Drug | Ranibizumab solution for injection was supplied in vials. Each vial contained ranibizumab concentration of 10mg/mL labeled as 0.5 mg/0.5 mL, corresponding to a 0.5 mg dose level. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial for single use only |
|
|
| Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the change in visual acuity at each visit compared to baseline | Month 1 to 12 months |
| Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center. | Month 1 to month 12 |
| Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. | Month 1 to month 12 |
| Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline. | Month 1 to 12 months |
| The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline | The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning. | Month 3,6 and 12 |
| Beijing |
| Beijing Municipality |
| 100730 |
| China |
| Novartis Investigative Site | Chongqing | Chongqing Municipality | 400042 | China |
| Novartis Investigative Site | Guangzhou | Guangdong | 510060 | China |
| Novartis Investigative Site | Shantou | Guangdong | 515041 | China |
| Novartis Investigative Site | Harbin | Heilongjiang | 150001 | China |
| Novartis Investigative Site | Wuhan | Hubei | 430070 | China |
| Novartis Investigative Site | Changsha | Hunan | 410011 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210006 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210029 | China |
| Novartis Investigative Site | Nantong | Jiangsu | 226000 | China |
| Novartis Investigative Site | Nanchang | Jiangxi | 330006 | China |
| Novartis Investigative Site | Qingdao | Shandong | 266011 | China |
| Novartis Investigative Site | Chengdu | Sichuan | 610041 | China |
| Novartis Investigative Site | Tianjin | Tianjin Municipality | 300020 | China |
| Novartis Investigative Site | Tianjin | Tianjin Municipality | 300070 | China |
| Novartis Investigative Site | Wenzhou | Zhejiang | 325027 | China |
| Novartis Investigative Site | Beijing | 100034 | China |
| Novartis Investigative Site | Beijing | 100176 | China |
| Novartis Investigative Site | Beijing | 100730 | China |
| Novartis Investigative Site | Chongqing | 400038 | China |
| Novartis Investigative Site | Shanghai | 200080 | China |
| Novartis Investigative Site | Shanghai | 200092 | China |
| Novartis Investigative Site | Hong Kong | Hong Kong | Hong Kong |
| Novartis Investigative Site | Ahmedabad | Gujarat | 380 016 | India |
| Novartis Investigative Site | Bhubaneswar | Odisha | 751 024 | India |
| Novartis Investigative Site | Bandung | West Java | 40117 | Indonesia |
| Novartis Investigative Site | Jakarta | 10430 | Indonesia |
| Novartis Investigative Site | Manila | National Capital Region | 1000 | Philippines |
| Novartis Investigative Site | San Juan City | Philippines | 1500 | Philippines |
| Novartis Investigative Site | Linkou District | 33305 | Taiwan |
| Novartis Investigative Site | Taipei | Taiwan |
| Novartis Investigative Site | Hanoi | 10000 | Vietnam |
| Novartis Investigative Site | Ho Chi Minh City | 70000 | Vietnam |
| Completed 3 Months |
|
| Discontinued Study Prior to 3 Months |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab 0.5 mg | PRN intravitreal injection |
| BG001 | Sham Injection | As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections |
| 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 | Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3 | Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 3 and compared to Baseline. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward | Posted | Mean | Standard Deviation | Letters | Baseline, 3 Months |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Change of Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 12 | Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward | Posted | Mean | Standard Deviation | Letters | Baseline, 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time | Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the change in visual acuity at each visit compared to baseline | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward | Posted | Mean | Standard Deviation | Letters | Month 1 to 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time | OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward | Posted | Mean | Standard Deviation | microns | Month 1 to month 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward | Posted | Number | Participants | Month 1 to month 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time | Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward | Posted | Number | Participants | Month 1 to 12 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline | The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. n= is the number of patients with a value for both baseline and the specific post-baseline visit. | Posted | Mean | Standard Deviation | Scores on a scale | Month 3,6 and 12 |
|
|
Not provided
The Safety Set consisted of all patients who received at least one application of study treatment and had at least one post-Baseline safety assessment. Patients were analyzed according to the treatment received. The statement that a patient had no AEs also constituted a safety assessment.
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 0.5 mg | PRN intravitreal injection | 11 | 190 | 96 | 190 | ||
| EG001 | Sham With Ranibizumab 0.5 mg | As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections | 5 | 56 | 32 | 56 | ||
| EG002 | Sham Without Ranibizumab 0.5 mg | Sham without Ranibizumab 0.5mg(hereafter referred to as sham group up to Month 3 and sham without ranibizumab after Month 3 | 1 | 5 | 3 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | 18.1 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | 18.1 | Systematic Assessment |
| |
| Angle closure glaucoma | Eye disorders | 18.1 | Systematic Assessment |
| |
| Keratitis | Eye disorders | 18.1 | Systematic Assessment |
| |
| Macular fibrosis | Eye disorders | 18.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | 18.1 | Systematic Assessment |
| |
| Endophthalmitis | Infections and infestations | 18.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 18.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | 18.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | 18.1 | Systematic Assessment |
| |
| Inflammatory pseudotumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 18.1 | Systematic Assessment |
| |
| Schwannoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 18.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | 18.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | 18.1 | Systematic Assessment |
| |
| Mediastinal cyst | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular insufficiency | Cardiac disorders | 18.1 | Systematic Assessment |
| |
| Asthenopia | Eye disorders | 18.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | 18.1 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | 18.1 | Systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | 18.1 | Systematic Assessment |
| |
| Conjunctival oedema | Eye disorders | 18.1 | Systematic Assessment |
| |
| Cystoid macular oedema | Eye disorders | 18.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | 18.1 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | 18.1 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | 18.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | 18.1 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | 18.1 | Systematic Assessment |
| |
| Eye swelling | Eye disorders | 18.1 | Systematic Assessment |
| |
| Foreign body sensation in eyes | Eye disorders | 18.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | 18.1 | Systematic Assessment |
| |
| Iris neovascularisation | Eye disorders | 18.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | 18.1 | Systematic Assessment |
| |
| Macular fibrosis | Eye disorders | 18.1 | Systematic Assessment |
| |
| Macular oedema | Eye disorders | 18.1 | Systematic Assessment |
| |
| Ocular discomfort | Eye disorders | 18.1 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | 18.1 | Systematic Assessment |
| |
| Ocular hypertension | Eye disorders | 18.1 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | 18.1 | Systematic Assessment |
| |
| Retinal ischaemia | Eye disorders | 18.1 | Systematic Assessment |
| |
| Retinal neovascularisation | Eye disorders | 18.1 | Systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | 18.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | 18.1 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | 18.1 | Systematic Assessment |
| |
| Vitreal cells | Eye disorders | 18.1 | Systematic Assessment |
| |
| Vitreous detachment | Eye disorders | 18.1 | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | 18.1 | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | 18.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | 18.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 18.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 18.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | 18.1 | Systematic Assessment |
| |
| Malaise | General disorders | 18.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | 18.1 | Systematic Assessment |
| |
| Dacryocystitis | Infections and infestations | 18.1 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | 18.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 18.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | 18.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 18.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 18.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | 18.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | 18.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | 18.1 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | 18.1 | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | 18.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 18.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | 18.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | 18.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | 18.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 18.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | 18.1 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 18.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 18.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 18.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 18.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 18.1 | 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 | 862-778-8300 |
| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D008269 | Macular Edema |
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
| D000069579 | Ranibizumab |
| 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 |
Not provided
Not provided
| Male |
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| Participants |
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| Participants |
|
|