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The study evaluated the efficacy and safety of two different dosing regimens of ranibizumab (either monthly injections or injections as-needed based on the stability of a patient's vision) in Chinese patients with wet age-related macular degeneration (AMD) . This study was to provide long-term safety data in the treatment of Chinese patients with wet AMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab 0.5 mg monthly | Experimental | Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by best-corrected visual acuity (BCVA) stabilization in the extension treatment period |
|
| Ranibizumab 0.5 mg pro re nata (PRN) | Experimental | PRN intravitreal injections of ranibizumab 0.5 mg guided by best-corrected visual acuity (BCVA) stabilization in the 23 month treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Intravitreal injections of 0.5 mg Ranibizumab |
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| Measure | Description | Time Frame |
|---|---|---|
| Average Change in Visual Acuity (Letters) From Month 3 to Month 4 Through Month 12 | 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 VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the VA averaged across all visits from Month 4 through 12 and the Month 3 Level of Visual Acuity (Letters) of the Study Eye. The treatment regimen up to Month 3 is the same in both treatment groups. | Month 3 to month 4 through Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Visual Acuity Change (Letters) From Month 3 to Month 4 Through Month 24 | 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 the difference between the average level of VA over all monthly post-baseline assessments from Month 4 to Month 24 and the Month 3 Level of VA. The treatment regimen up to Month 3 is the same in both treatment groups. |
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Key Inclusion criteria:
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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 |
A total of 334 patients were randomized in this study. One patient was mis-randomized to ranibizumab 0.5 monthly group and another patient was discontinued due to AE. Neither patient received any treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab 0.5 mg Monthly | Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period |
| FG001 | Ranibizumab 0.5 mg PRN |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Core Period |
|
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| Month 3 to month 4 through Month 24 |
| Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and Month 1 Through Month 24 | 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 the difference between VA averaged across all visits from Month 1 through Month 12 (24) and the baseline VA level | Baseline to Month 24 |
| Change From Baseline in Visual Acuity (Letters) of the Study Eye 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 | Baseline to 24 months |
| Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Visual acuity (VA) was 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 improved by equal or more than 5, 10, 15,or 30 letters of VA as compared to baseline. | Baseline to Month 24 |
| Number of Patients With a 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. | Baseline to Month 24 |
| Number of Patients With a Best Corrected Visual Acuity (BCVA) of More of 73 Letters or More | 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 Month 12 and Month 24 whether a patient had a VA score of 73 or more letters | Month 12 and 24 |
| Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Optical coherence tomography(OCT) 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 Ns in the rows is the number of patients with a value for both baseline and the specific post-baseline visit | Baseline to Month 24 |
| Duration of Ranibizumab Treatment Free Interval in the Study Eye up to Month 24 | This outcome measure describes duration of treatment-free intervals. Treatment-free interval is defined as the number of visits (whether attended or not) where ranibizumab was not administered. n= the number of patients who had at least one ranibizumab treatment interruption | up to month 24 |
| Duration of Ranibizumab Treatment Free Interval in the Study Eye Prior to Month 12 | This outcome measure describes duration of treatment-free intervals prior to month 12. Treatment-free interval is defined as the number of visits (whether attended or not) where ranibizumab was not administered. n= the number of patients who had at least one ranibizumab treatment interruption Treatment-free interval is analyzed in the Ranibizumab 0.5 mg PRN group only. It is not analyzed in the Ranibizumab 0.5 mg monthly group because, by protocol design, these participants receive treatment monthly. Therefore, the analysis does not apply to this group. | prior to month 12 |
| Duration of Active Treatment Phase Prior to Month 12 | Prior to month 12 |
| Duration of Active Treatment Phase up to Month 24 | up to month 24 |
| Beijing |
| Beijing Municipality |
| 100730 |
| China |
| Novartis Investigative Site | Chongqing | Chongqing Municipality | 400042 | China |
| Novartis Investigative Site | Lanzhou | Gansu | 730030 | China |
| Novartis Investigative Site | Harbin | Heilongjiang | 150001 | China |
| Novartis Investigative Site | Wuhan | Hubei | 430060 | China |
| Novartis Investigative Site | Wuhan | Hubei | 430070 | China |
| Novartis Investigative Site | Changsha | Hunan | 410011 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210029 | China |
| Novartis Investigative Site | Nanchang | Jiangxi | 330006 | China |
| Novartis Investigative Site | Shenyang | Liaoning | 110011 | China |
| Novartis Investigative Site | Qingdao | Shandong | 2666000 | China |
| Novartis Investigative Site | Taiyuan | Shanxi | 030002 | 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 | 100044 | China |
| Novartis Investigative Site | Beijing | 100176 | China |
| Novartis Investigative Site | Chongqing | 400038 | China |
| Novartis Investigative Site | Shanghai | 200031 | China |
| Novartis Investigative Site | Shanghai | 200080 | China |
| Novartis Investigative Site | Shanghai | 200092 | China |
PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period |
| Full Analysis Set |
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| Per Protocol Set |
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| Safety Set |
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| COMPLETED |
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| NOT COMPLETED |
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| Extension Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab 0.5 mg Monthly | Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period |
| BG001 | Ranibizumab 0.5 mg PRN | PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period |
| 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 |
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| 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 Month 3 to Month 4 Through Month 12 | 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 VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the VA averaged across all visits from Month 4 through 12 and the Month 3 Level of Visual Acuity (Letters) of the Study Eye. The treatment regimen up to Month 3 is the same in both treatment groups. | Full Analysis Set: Consisted of all patients to whom study treatment was assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward | Posted | Mean | Standard Deviation | Letters | Month 3 to month 4 through Month 12 |
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| Secondary | Average Visual Acuity Change (Letters) From Month 3 to Month 4 Through Month 24 | 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 the difference between the average level of VA over all monthly post-baseline assessments from Month 4 to Month 24 and the Month 3 Level of VA. The treatment regimen up to Month 3 is the same in both treatment groups. | Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward | Posted | Mean | Standard Deviation | Letters | Month 3 to month 4 through Month 24 |
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| Secondary | Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and Month 1 Through Month 24 | 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 the difference between VA averaged across all visits from Month 1 through Month 12 (24) and the baseline VA level | Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward | Posted | Mean | Standard Deviation | Letters | Baseline to Month 24 |
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| Secondary | Change From Baseline in Visual Acuity (Letters) of the Study Eye 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 | Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward | Posted | Mean | Standard Deviation | letters | Baseline to 24 months |
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| Secondary | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Visual acuity (VA) was 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 improved by equal or more than 5, 10, 15,or 30 letters of VA as compared to baseline. | Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward | Posted | Number | Patients | Baseline to Month 24 |
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| Secondary | Number of Patients With a 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. | Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward | Posted | Number | Patients | Baseline to Month 24 |
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| Secondary | Number of Patients With a Best Corrected Visual Acuity (BCVA) of More of 73 Letters or More | 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 Month 12 and Month 24 whether a patient had a VA score of 73 or more letters | Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward | Posted | Number | Patients | Month 12 and 24 |
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| Secondary | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Optical coherence tomography(OCT) 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 Ns in the rows is the number of patients with a value for both baseline and the specific post-baseline visit | Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (LOCF)= last observation carried forward | Posted | Mean | Standard Deviation | microns | Baseline to Month 24 |
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| Secondary | Duration of Ranibizumab Treatment Free Interval in the Study Eye up to Month 24 | This outcome measure describes duration of treatment-free intervals. Treatment-free interval is defined as the number of visits (whether attended or not) where ranibizumab was not administered. n= the number of patients who had at least one ranibizumab treatment interruption | Safety set consisted of all patients who received at least one application of ranibizumab ( active study treatment) and had at least one post-baseline safety assessment. A patient who had no AEs also constituted a safety assessment | Posted | Mean | Standard Deviation | Months | up to month 24 |
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| Secondary | Duration of Ranibizumab Treatment Free Interval in the Study Eye Prior to Month 12 | This outcome measure describes duration of treatment-free intervals prior to month 12. Treatment-free interval is defined as the number of visits (whether attended or not) where ranibizumab was not administered. n= the number of patients who had at least one ranibizumab treatment interruption Treatment-free interval is analyzed in the Ranibizumab 0.5 mg PRN group only. It is not analyzed in the Ranibizumab 0.5 mg monthly group because, by protocol design, these participants receive treatment monthly. Therefore, the analysis does not apply to this group. | Safety set consisted of all patients who received at least one application of ranibizumab ( active study treatment) and had at least one post-baseline safety assessment. A patient who had no AEs also constituted a safety assessment | Posted | Mean | Standard Deviation | Months | prior to month 12 |
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| Secondary | Duration of Active Treatment Phase Prior to Month 12 | Safety set consisted of all patients who received at least one application of ranibizumab ( active study treatment) and had at least one post-baseline safety assessment. A patient who had no AEs also constituted a safety assessment | Posted | Mean | Standard Deviation | Months | Prior to month 12 |
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| Secondary | Duration of Active Treatment Phase up to Month 24 | Safety set consisted of all patients who received at least one application of ranibizumab ( active study treatment) and had at least one post-baseline safety assessment. A patient who had no AEs also constituted a safety assessment | Posted | Mean | Standard Deviation | Months | up to month 24 |
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Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
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| 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 Monthly | Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period | 24 | 166 | 107 | 166 | ||
| EG001 | Ranibizumab 0.5 mg PRN | PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period | 24 | 166 | 87 | 166 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | 18.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | 18.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | 18.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | 18.1 | Systematic Assessment |
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| Cardiac discomfort | Cardiac disorders | 18.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | 18.1 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | 18.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | 18.1 | Systematic Assessment |
| |
| Sudden hearing loss | Ear and labyrinth disorders | 18.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | 18.1 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | 18.1 | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | 18.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | 18.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | 18.1 | Systematic Assessment |
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| Gallbladder polyp | Hepatobiliary disorders | 18.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 18.1 | Systematic Assessment |
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| Tinea pedis | Infections and infestations | 18.1 | Systematic Assessment |
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| Cataract traumatic | Injury, poisoning and procedural complications | 18.1 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | 18.1 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | 18.1 | Systematic Assessment |
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| Exostosis | Musculoskeletal and connective tissue disorders | 18.1 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | 18.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | 18.1 | Systematic Assessment |
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| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | 18.1 | Systematic Assessment |
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| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 18.1 | Systematic Assessment |
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| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 18.1 | Systematic Assessment |
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| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 18.1 | Systematic Assessment |
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| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 18.1 | Systematic Assessment |
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| Oesophageal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 18.1 | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 18.1 | Systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | 18.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | 18.1 | Systematic Assessment |
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| Cerebral ischaemia | Nervous system disorders | 18.1 | Systematic Assessment |
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| Lacunar infarction | Nervous system disorders | 18.1 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | 18.1 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
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| Emphysema | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
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| Drug eruption | Skin and subcutaneous tissue disorders | 18.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | 18.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac discomfort | Cardiac disorders | 18.1 | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | 18.1 | Systematic Assessment |
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| Age-related macular degeneration | Eye disorders | 18.1 | Systematic Assessment |
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| Cataract | Eye disorders | 18.1 | Systematic Assessment |
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| Choroidal neovascularisation | Eye disorders | 18.1 | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | 18.1 | Systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | 18.1 | Systematic Assessment |
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| Conjunctivitis allergic | Eye disorders | 18.1 | Systematic Assessment |
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| Dry eye | Eye disorders | 18.1 | Systematic Assessment |
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| Eye pain | Eye disorders | 18.1 | Systematic Assessment |
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| Foreign body sensation in eyes | Eye disorders | 18.1 | Systematic Assessment |
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| Glaucoma | Eye disorders | 18.1 | Systematic Assessment |
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| Lacrimation increased | Eye disorders | 18.1 | Systematic Assessment |
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| Macular fibrosis | Eye disorders | 18.1 | Systematic Assessment |
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| Macular oedema | Eye disorders | 18.1 | Systematic Assessment |
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| Neovascular age-related macular degeneration | Eye disorders | 18.1 | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | 18.1 | Systematic Assessment |
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| Retinal haemorrhage | Eye disorders | 18.1 | Systematic Assessment |
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| Retinal tear | Eye disorders | 18.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | 18.1 | Systematic Assessment |
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| Visual acuity reduced | Eye disorders | 18.1 | Systematic Assessment |
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| Vitreous detachment | Eye disorders | 18.1 | Systematic Assessment |
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| Chronic gastritis | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Malaise | General disorders | 18.1 | Systematic Assessment |
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| Pyrexia | General disorders | 18.1 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | 18.1 | Systematic Assessment |
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| Hepatic steatosis | Hepatobiliary disorders | 18.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | 18.1 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | 18.1 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | 18.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | 18.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | 18.1 | Systematic Assessment |
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| Pulpitis dental | Infections and infestations | 18.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | 18.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | 18.1 | Systematic Assessment |
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| Animal bite | Injury, poisoning and procedural complications | 18.1 | Systematic Assessment |
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| Blood glucose increased | Investigations | 18.1 | Systematic Assessment |
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| Blood pressure increased | Investigations | 18.1 | Systematic Assessment |
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| Blood uric acid increased | Investigations | 18.1 | Systematic Assessment |
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| Intraocular pressure increased | Investigations | 18.1 | Systematic Assessment |
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| Visual acuity tests abnormal | Investigations | 18.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | 18.1 | Systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | 18.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | 18.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | 18.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 18.1 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | 18.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | 18.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue 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 |
|---|---|
| D008268 | Macular Degeneration |
| D014786 | Vision Disorders |
| D057092 | Geographic Atrophy |
| D057135 | Wet Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| 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 |
|---|---|
| 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
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