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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05476926
Registration number
NCT05476926
Ethics application status
Date submitted
25/07/2022
Date registered
27/07/2022
Titles & IDs
Public title
A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products
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Scientific title
Real-World, Long-Term Data Collection to Gain Clinical Insights Into Roche Ophthalmology Products (VOYAGER STUDY)
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Secondary ID [1]
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0
MR41927
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Universal Trial Number (UTN)
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Trial acronym
VOYAGER
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neovascular Age-related Macular Degeneration
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Diabetic Macular Edema
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Condition category
Condition code
Eye
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0
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0
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - Faricimab
Other interventions - Port Delivery System with Ranibizumab
Faricimab for nAMD -
Faricimab for DME -
Port Delivery System with Ranibizumab for nAMD -
Treatment: Drugs: Faricimab
Faricimab will be administered as per local clinical practice and local labeling.
Other interventions: Port Delivery System with Ranibizumab
The port delivery system with ranibizumab will be administered as per local clinical practice and local labeling.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Visual Acuity from Baseline at 1 Year, per Approved Retinal Indication and Product
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Assessment method [1]
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Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
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Timepoint [1]
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Baseline and 1 year
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Secondary outcome [1]
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Change in Visual Acuity from Baseline Over Time, per Approved Retinal Indication and Product
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Assessment method [1]
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Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
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Timepoint [1]
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Baseline, 3 and 6 months, and 2, 3, 4, and 5 years
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Secondary outcome [2]
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Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other) Over Time, per Approved Retinal Indication and Product
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Assessment method [2]
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0
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Timepoint [2]
0
0
Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years
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Secondary outcome [3]
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0
Number of Treatments per Year, per Approved Retinal Indication and Product
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Assessment method [3]
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0
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Timepoint [3]
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1, 2, 3, 4, and 5 years
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Secondary outcome [4]
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Cumulative Time Spent on Each Treatment per Eye, Overall and per Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other), per Approved Retinal Indication and Product
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Assessment method [4]
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Timepoint [4]
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From Baseline until end of study (up to 5 years)
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Secondary outcome [5]
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Percentage of Eyes with Treatment Switch by Reason for Switch Over Time, per Approved Retinal Indication and Product
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Assessment method [5]
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0
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Timepoint [5]
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At 3 and 6 months, and 1, 2, 3, 4, and 5 years
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Secondary outcome [6]
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Percentage of Eyes with Treatment Regimen Switch (Fixed, Treat-and-Extend, As Needed, or Other) by Reason for Switch Over Time, per Approved Retinal Indication and Product
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Assessment method [6]
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0
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Timepoint [6]
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0
At 3 and 6 months, and 1, 2, 3, 4, and 5 years
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Secondary outcome [7]
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Total Number of Visits per Year, per Approved Retinal Indication and Product
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Assessment method [7]
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0
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Timepoint [7]
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1, 2, 3, 4, and 5 years
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Secondary outcome [8]
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Number of Visits With or Without Treatment per Year, per Approved Retinal Indication and Product
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Assessment method [8]
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0
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Timepoint [8]
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1, 2, 3, 4, and 5 years
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Secondary outcome [9]
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Time Interval Between Treatments per Year, per Approved Retinal Indication and Product
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Assessment method [9]
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0
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Timepoint [9]
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1, 2, 3, 4, and 5 years
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Secondary outcome [10]
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Number of Eyes Treated with Ocular Concomitant and Subsequent Medications by Type and Frequency During the Study, per Approved Retinal Indication and Product
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Assessment method [10]
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0
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Timepoint [10]
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0
From Baseline until end of study (up to 5 years)
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Secondary outcome [11]
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0
Change in Visual Acuity from Baseline Over Time, According to Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other), per Approved Retinal Indication and Product
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Assessment method [11]
0
0
Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
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Timepoint [11]
0
0
Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years
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Secondary outcome [12]
0
0
Change in Visual Acuity from Baseline Over Time, According to Number of Treatments, per Approved Retinal Indication and Product
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Assessment method [12]
0
0
Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
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Timepoint [12]
0
0
Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years
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Secondary outcome [13]
0
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Change in Visual Acuity from Baseline Over Time, According to Total Number of Visits, per Approved Retinal Indication and Product
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Assessment method [13]
0
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Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
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Timepoint [13]
0
0
Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years
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Secondary outcome [14]
0
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Change in Visual Acuity from Baseline Over Time, According to Treatment Schedule, per Approved Retinal Indication and Product
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Assessment method [14]
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Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
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Timepoint [14]
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0
Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years
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Secondary outcome [15]
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Change in Central Subfield Thickness (CST) from Baseline Over Time, per Approved Retinal Indication and Product
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Assessment method [15]
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0
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Timepoint [15]
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Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years
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Secondary outcome [16]
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Number of Participants with at Least One Ocular Adverse Event, by Severity and Seriousness, per Approved Retinal Indication and Product
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Assessment method [16]
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Severity and seriousness will be independently assessed for each adverse event (AE). The terms "severe" and "serious" are not synonymous. Severity refers to the intensity of an AE (e.g., rated as mild, moderate, or severe); the event itself may be of relatively minor medical significance.
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Timepoint [16]
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From Baseline until end of study (up to 5 years)
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Secondary outcome [17]
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Number of Participants with at Least One Non-Ocular Adverse Event, by Severity and Seriousness, per Approved Retinal Indication and Product
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Assessment method [17]
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Severity and seriousness will be independently assessed for each adverse event (AE). The terms "severe" and "serious" are not synonymous. Severity refers to the intensity of an AE (e.g., rated as mild, moderate, or severe); the event itself may be of relatively minor medical significance.
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Timepoint [17]
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From Baseline until end of study (up to 5 years)
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Eligibility
Key inclusion criteria
1. Have provided informed consent, as required per local regulations 2.a) Adult patient, as defined by local regulations and local product label, who is newly initiating treatment (or initiated treatment in the previous visit) with a specified approved Roche ophthalmology product in retinal indication of interest for this study in at least one eye, according to the investigator's discretion in routine clinical practice; OR 2.b) Adult patient, as defined by local regulations and local product label, who is continuing treatment with any specified approved Roche ophthalmology product in retinal indication of interest for this study in at least one eye after initiating that treatment in a Roche interventional trial.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Concomitant participation of the patient in an investigational ophthalmology clinical trial that includes receipt of any investigational drug or procedure within the last 28 days prior to enrollment (this restriction does not apply to patients who are rolling over from Roche interventional studies and continuing treatment with any specified approved Roche ophthalmology product in retinal indication of interest for this study)
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/11/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2027
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Actual
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Sample size
Target
5000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Retina and Macula Specialists - Hurstville
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Recruitment hospital [2]
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Sydney West Retina - Westmead
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Recruitment hospital [3]
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Sunshine Coast University Hospital - Geebung
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Recruitment hospital [4]
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Centre For Eye Research Australia - East Melbourne
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Recruitment hospital [5]
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East Melbourne Eye Group - East Melbourne
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Recruitment hospital [6]
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Cabrini Hospital Malvern - Malvern
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Recruitment hospital [7]
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Lions Outback Vision Service in Broome - Broome
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Recruitment hospital [8]
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The Lions Eye Institute - Nedlands
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Recruitment postcode(s) [1]
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2220 - Hurstville
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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4034 - Geebung
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Recruitment postcode(s) [4]
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3002 - East Melbourne
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Recruitment postcode(s) [5]
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3144 - Malvern
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Recruitment postcode(s) [6]
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6725 - Broome
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Florida
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Illinois
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United States of America
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Kentucky
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United States of America
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Maryland
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United States of America
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Michigan
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United States of America
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Pennsylvania
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South Carolina
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Tennessee
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Argentina
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Ciudad Autonoma de Buenos Aires
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Cordoba
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Chiba
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Fukuoka
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Gifu
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Hokkaido
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Japan
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State/province [100]
0
0
Hyogo
Query!
Country [101]
0
0
Japan
Query!
State/province [101]
0
0
Ibaraki
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Country [102]
0
0
Japan
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State/province [102]
0
0
Kagawa
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Country [103]
0
0
Japan
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State/province [103]
0
0
Kanagawa
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Country [104]
0
0
Japan
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State/province [104]
0
0
Meguro-ku
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Country [105]
0
0
Japan
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State/province [105]
0
0
Mie
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Country [106]
0
0
Japan
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State/province [106]
0
0
Nagano
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Country [107]
0
0
Japan
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State/province [107]
0
0
Nagasaki
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Country [108]
0
0
Japan
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State/province [108]
0
0
Osaka-shi
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Country [109]
0
0
Japan
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State/province [109]
0
0
Osaka
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Country [110]
0
0
Japan
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State/province [110]
0
0
Saitama
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Country [111]
0
0
Japan
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State/province [111]
0
0
Shiga
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Country [112]
0
0
Japan
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State/province [112]
0
0
Suita
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Country [113]
0
0
Japan
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State/province [113]
0
0
Takatsuki-shi
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Country [114]
0
0
Japan
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State/province [114]
0
0
Tokushima
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Country [115]
0
0
Japan
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State/province [115]
0
0
Tokyo
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Country [116]
0
0
Japan
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State/province [116]
0
0
Toyoake-shi
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Country [117]
0
0
Japan
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State/province [117]
0
0
Yamaguchi
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Country [118]
0
0
Japan
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State/province [118]
0
0
Yoshida-gun
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Country [119]
0
0
Puerto Rico
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State/province [119]
0
0
Arecibo
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Country [120]
0
0
Singapore
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State/province [120]
0
0
Singapore
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Country [121]
0
0
Spain
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State/province [121]
0
0
Barcelona
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Country [122]
0
0
Spain
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State/province [122]
0
0
LA Coruña
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Country [123]
0
0
Spain
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State/province [123]
0
0
LAS Palmas
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Country [124]
0
0
Spain
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State/province [124]
0
0
Madrid
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Country [125]
0
0
Spain
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State/province [125]
0
0
Malaga
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Country [126]
0
0
Spain
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State/province [126]
0
0
Pontevedra
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Country [127]
0
0
Spain
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State/province [127]
0
0
Vizcaya
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Country [128]
0
0
Spain
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State/province [128]
0
0
Burgos
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Country [129]
0
0
Spain
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State/province [129]
0
0
Cadiz
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Country [130]
0
0
Spain
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State/province [130]
0
0
Cordoba
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Country [131]
0
0
Spain
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State/province [131]
0
0
Murcia
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Country [132]
0
0
Spain
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State/province [132]
0
0
Sevilla
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Country [133]
0
0
Spain
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State/province [133]
0
0
Valladolid
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Country [134]
0
0
Spain
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State/province [134]
0
0
Zaragoza
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Country [135]
0
0
Switzerland
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State/province [135]
0
0
Aarau
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Country [136]
0
0
Switzerland
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State/province [136]
0
0
Bern
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Country [137]
0
0
Switzerland
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State/province [137]
0
0
Binningen
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Country [138]
0
0
Switzerland
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State/province [138]
0
0
Lausanne
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Country [139]
0
0
Switzerland
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State/province [139]
0
0
Lugano
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Country [140]
0
0
Switzerland
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State/province [140]
0
0
Luzern
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Country [141]
0
0
Switzerland
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State/province [141]
0
0
Zürich
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Country [142]
0
0
United Arab Emirates
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State/province [142]
0
0
Abu dhabi
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Country [143]
0
0
United Arab Emirates
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State/province [143]
0
0
Dubai
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Country [144]
0
0
United Kingdom
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State/province [144]
0
0
Bedford
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Country [145]
0
0
United Kingdom
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State/province [145]
0
0
Belfast
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Country [146]
0
0
United Kingdom
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State/province [146]
0
0
Birmingham
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Country [147]
0
0
United Kingdom
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State/province [147]
0
0
Bradford
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Country [148]
0
0
United Kingdom
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State/province [148]
0
0
Bristol
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Country [149]
0
0
United Kingdom
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State/province [149]
0
0
Cardiff
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Country [150]
0
0
United Kingdom
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State/province [150]
0
0
Cheltenham
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Country [151]
0
0
United Kingdom
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State/province [151]
0
0
Colchester
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Country [152]
0
0
United Kingdom
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State/province [152]
0
0
Coventry
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Country [153]
0
0
United Kingdom
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State/province [153]
0
0
Frimley
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Country [154]
0
0
United Kingdom
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State/province [154]
0
0
Harrow
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Country [155]
0
0
United Kingdom
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State/province [155]
0
0
Hull
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Country [156]
0
0
United Kingdom
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State/province [156]
0
0
Leeds
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Country [157]
0
0
United Kingdom
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State/province [157]
0
0
Liverpool
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Country [158]
0
0
United Kingdom
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State/province [158]
0
0
London
Query!
Country [159]
0
0
United Kingdom
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State/province [159]
0
0
Maidstone, Kent
Query!
Country [160]
0
0
United Kingdom
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State/province [160]
0
0
Manchester
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Country [161]
0
0
United Kingdom
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State/province [161]
0
0
Newcastle upon Tyne
Query!
Country [162]
0
0
United Kingdom
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State/province [162]
0
0
Norfolk
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Country [163]
0
0
United Kingdom
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State/province [163]
0
0
Oxford
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Country [164]
0
0
United Kingdom
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State/province [164]
0
0
Sheffield
Query!
Country [165]
0
0
United Kingdom
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State/province [165]
0
0
Southampton
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Country [166]
0
0
United Kingdom
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State/province [166]
0
0
Sunderland
Query!
Country [167]
0
0
United Kingdom
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State/province [167]
0
0
Torquay
Query!
Country [168]
0
0
United Kingdom
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State/province [168]
0
0
Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
Query!
Summary
Brief summary
The VOYAGER study is a primary data collection, non-interventional, prospective, multinational, multicenter study. It is designed to collect real-world, long-term data to explore long-term effectiveness, safety, clinical insights, treatment patterns, and factors driving the treatment decisions among patients being treated with specified Roche ophthalmology products (Faricimab and Port Delivery System with Ranibizumab) in approved retinal indications (neovascular age-related macular degeneration \[nAMD\] and diabetic macular edema \[DME\]) in routine clinical practice. This study will not provide or make recommendations on use of any products including Roche products; treatment decisions will be determined by the treating physician and must be made independently to the decision to participate in this study. Participation in this study will not change or influence a patient's standard of care in any way.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05476926
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Trial related presentations / publications
Query!
Public notes
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Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
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Country
0
0
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Phone
0
0
Query!
Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Reference Study ID Number: MR41927 https://forpatients.roche.com/
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Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
888-662-6728 (U.S. Only)
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Fax
0
0
Query!
Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05476926