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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
Scientific title
Real-World, Long-Term Data Collection to Gain Clinical Insights Into Roche Ophthalmology Products (VOYAGER STUDY)
Secondary ID [1] 0 0
MR41927
Universal Trial Number (UTN)
Trial acronym
VOYAGER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neovascular Age-related Macular Degeneration 0 0
Diabetic Macular Edema 0 0
Retinal Vein Occlusion 0 0
Branch Retinal Vein Occlusion 0 0
Central Retinal Vein Occlusion 0 0
Hemi-retinal Vein Occlusion 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Faricimab
Other interventions - Port Delivery System with Ranibizumab

Cohort 1: Faricimab for nAMD -

Cohort 2: Faricimab for DME -

Cohort 3: Port Delivery System with Ranibizumab for nAMD -

Cohort 4: Faricimab for BRVO -

Cohort 5: Faricimab for CRVO/HRVO -


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.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Visual Acuity from Baseline at 1 Year, per Approved Retinal Indication and Product
Assessment method [1] 0 0
Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
Timepoint [1] 0 0
Baseline and 1 year
Secondary outcome [1] 0 0
Change in Visual Acuity from Baseline Over Time, per Approved Retinal Indication and Product
Assessment method [1] 0 0
Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
Timepoint [1] 0 0
Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)
Secondary outcome [2] 0 0
Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other) Over Time, per Approved Retinal Indication and Product
Assessment method [2] 0 0
Timepoint [2] 0 0
Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)
Secondary outcome [3] 0 0
Number of Treatments Over Time, per Approved Retinal Indication and Product
Assessment method [3] 0 0
Timepoint [3] 0 0
At 3, 6, and 12 months, and annually thereafter (up to 5 years)
Secondary outcome [4] 0 0
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
Assessment method [4] 0 0
Timepoint [4] 0 0
From Baseline until end of study (up to 5 years)
Secondary outcome [5] 0 0
Percentage of Eyes with Treatment Switch by Reason for Switch Over Time, per Approved Retinal Indication and Product
Assessment method [5] 0 0
Timepoint [5] 0 0
At 3, 6, and 12 months, and annually thereafter (up to 5 years)
Secondary outcome [6] 0 0
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
Assessment method [6] 0 0
Timepoint [6] 0 0
At 3, 6, and 12 months, and annually thereafter (up to 5 years)
Secondary outcome [7] 0 0
Total Number of Visits per Year, per Approved Retinal Indication and Product
Assessment method [7] 0 0
Timepoint [7] 0 0
Annually (up to 5 years)
Secondary outcome [8] 0 0
Number of Visits With or Without Treatment per Year, per Approved Retinal Indication and Product
Assessment method [8] 0 0
Timepoint [8] 0 0
Annually (up to 5 years)
Secondary outcome [9] 0 0
Time Interval Between Treatments per Year, per Approved Retinal Indication and Product
Assessment method [9] 0 0
Timepoint [9] 0 0
Annually (up to 5 years)
Secondary outcome [10] 0 0
Number of Eyes Treated with Ocular Concomitant and Subsequent Medications by Type and Frequency During the Study, per Approved Retinal Indication and Product
Assessment method [10] 0 0
Timepoint [10] 0 0
From Baseline until end of study (up to 5 years)
Secondary outcome [11] 0 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
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.
Timepoint [11] 0 0
Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)
Secondary outcome [12] 0 0
Change in Visual Acuity from Baseline Over Time, According to Number of Treatments, per Approved Retinal Indication and Product
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.
Timepoint [12] 0 0
Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)
Secondary outcome [13] 0 0
Change in Visual Acuity from Baseline Over Time, According to Total Number of Visits, per Approved Retinal Indication and Product
Assessment method [13] 0 0
Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
Timepoint [13] 0 0
Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)
Secondary outcome [14] 0 0
Change in Visual Acuity from Baseline Over Time, According to Treatment Schedule, per Approved Retinal Indication and Product
Assessment method [14] 0 0
Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
Timepoint [14] 0 0
Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)
Secondary outcome [15] 0 0
Change in Central Subfield Thickness (CST) from Baseline Over Time, per Approved Retinal Indication and Product
Assessment method [15] 0 0
Timepoint [15] 0 0
Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)
Secondary outcome [16] 0 0
Number of Participants with at Least One Ocular Adverse Event, by Severity and Seriousness, per Approved Retinal Indication and Product
Assessment method [16] 0 0
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.
Timepoint [16] 0 0
From Baseline until end of study (up to 5 years)
Secondary outcome [17] 0 0
Number of Participants with at Least One Non-Ocular Adverse Event, by Severity and Seriousness, per Approved Retinal Indication and Product
Assessment method [17] 0 0
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.
Timepoint [17] 0 0
From Baseline until end of study (up to 5 years)

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Retina and Macula Specialists - Hurstville
Recruitment hospital [2] 0 0
Sydney West Retina - Westmead
Recruitment hospital [3] 0 0
Sunshine Coast University Hospital - Geebung
Recruitment hospital [4] 0 0
Centre For Eye Research Australia - East Melbourne
Recruitment hospital [5] 0 0
East Melbourne Eye Group - East Melbourne
Recruitment hospital [6] 0 0
Cabrini Hospital Malvern - Malvern
Recruitment hospital [7] 0 0
Lions Outback Vision Service in Broome - Broome
Recruitment hospital [8] 0 0
The Lions Eye Institute - Nedlands
Recruitment postcode(s) [1] 0 0
2220 - Hurstville
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4034 - Geebung
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3144 - Malvern
Recruitment postcode(s) [6] 0 0
6725 - Broome
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Argentina
State/province [15] 0 0
Ciudad Autonoma Buenos Aires
Country [16] 0 0
Argentina
State/province [16] 0 0
Ciudad Autonoma de Buenos Aires
Country [17] 0 0
Argentina
State/province [17] 0 0
Cordoba
Country [18] 0 0
Argentina
State/province [18] 0 0
San Miguel de Tucuman
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Sofia
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Varna
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Chile
State/province [24] 0 0
Las Condes
Country [25] 0 0
Chile
State/province [25] 0 0
Vitacura
Country [26] 0 0
Croatia
State/province [26] 0 0
Osijek
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Croatia
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Rijeka
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Croatia
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Zagreb
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Czechia
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Praha 6
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France
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Aix En Provence
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Bordeaux Floirac
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France
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Bordeaux
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France
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Creteil cedex
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Dijon Cedex
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Ecully
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Grenoble
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La Rochelle cedex
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Lagord
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Le Chesnay Cedex
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Lille
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Lyon
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Marseille
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Montargis
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Montauban
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Montbonnot-Saint-Martin
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Montpellier
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France
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Nantes cedex 1
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France
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Nantes
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France
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Nice
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France
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Osny
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France
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Paris
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Poities Cedex
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Saint Etienne
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Saint-jean
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St Cyr Sur Loire
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St Herblain
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Toulouse
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Germany
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Berlin
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Chemnitz
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Germany
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Cottbus
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Dessau - Roßlau
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Germany
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Dresden
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Germany
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Erlangen
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Frankfurt
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Greifswald
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Halle
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Hannover
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Heidelberg
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Jena
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Koeln
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Germany
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Leipzig
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Germany
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Ludwigshafen
Country [73] 0 0
Germany
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Magdeburg
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Germany
State/province [74] 0 0
Mannheim
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Germany
State/province [75] 0 0
München
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Germany
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Rostock
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Germany
State/province [77] 0 0
Sulzbach
Country [78] 0 0
Germany
State/province [78] 0 0
Würzburg
Country [79] 0 0
Israel
State/province [79] 0 0
Haifa
Country [80] 0 0
Israel
State/province [80] 0 0
Holon
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Israel
State/province [81] 0 0
Jerusalem
Country [82] 0 0
Israel
State/province [82] 0 0
Kfar- Saba
Country [83] 0 0
Israel
State/province [83] 0 0
Petah Tikva
Country [84] 0 0
Israel
State/province [84] 0 0
Tel Aviv
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Italy
State/province [85] 0 0
Calabria
Country [86] 0 0
Italy
State/province [86] 0 0
Campania
Country [87] 0 0
Italy
State/province [87] 0 0
Friuli-Venezia Giulia
Country [88] 0 0
Italy
State/province [88] 0 0
Lazio
Country [89] 0 0
Italy
State/province [89] 0 0
Liguria
Country [90] 0 0
Italy
State/province [90] 0 0
Lombardia
Country [91] 0 0
Italy
State/province [91] 0 0
Piemonte
Country [92] 0 0
Italy
State/province [92] 0 0
Puglia
Country [93] 0 0
Italy
State/province [93] 0 0
Sardegna
Country [94] 0 0
Italy
State/province [94] 0 0
Sicilia
Country [95] 0 0
Italy
State/province [95] 0 0
Veneto
Country [96] 0 0
Japan
State/province [96] 0 0
Aichi
Country [97] 0 0
Japan
State/province [97] 0 0
Akita-shi
Country [98] 0 0
Japan
State/province [98] 0 0
Chiba
Country [99] 0 0
Japan
State/province [99] 0 0
Chuo-shi
Country [100] 0 0
Japan
State/province [100] 0 0
Fukuoka
Country [101] 0 0
Japan
State/province [101] 0 0
Gifu
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Japan
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Hiroshima
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Japan
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Hokkaido
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Japan
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Hyogo
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Ibaraki
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Kagawa
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Japan
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Kanagawa
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Japan
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Meguro-ku
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Japan
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Mie
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Japan
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Miyagi
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Japan
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Nagano
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Japan
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Nagasaki
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Japan
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Osaka-shi
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Shiga
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Japan
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Shizuoka
Country [118] 0 0
Japan
State/province [118] 0 0
Suita
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Japan
State/province [119] 0 0
Takatsuki-shi
Country [120] 0 0
Japan
State/province [120] 0 0
Tokushima
Country [121] 0 0
Japan
State/province [121] 0 0
Tokyo
Country [122] 0 0
Japan
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Toyoake-shi
Country [123] 0 0
Japan
State/province [123] 0 0
Yamagata
Country [124] 0 0
Japan
State/province [124] 0 0
Yamaguchi
Country [125] 0 0
Japan
State/province [125] 0 0
Yoshida-gun
Country [126] 0 0
Puerto Rico
State/province [126] 0 0
Arecibo
Country [127] 0 0
Singapore
State/province [127] 0 0
Singapore
Country [128] 0 0
Spain
State/province [128] 0 0
Barcelona
Country [129] 0 0
Spain
State/province [129] 0 0
LA Coruña
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Spain
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LAS Palmas
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Pontevedra
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Spain
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Vizcaya
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Spain
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Burgos
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Spain
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Cadiz
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Spain
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Cordoba
Country [138] 0 0
Spain
State/province [138] 0 0
Murcia
Country [139] 0 0
Spain
State/province [139] 0 0
Sevilla
Country [140] 0 0
Spain
State/province [140] 0 0
Valladolid
Country [141] 0 0
Spain
State/province [141] 0 0
Zaragoza
Country [142] 0 0
Switzerland
State/province [142] 0 0
Aarau
Country [143] 0 0
Switzerland
State/province [143] 0 0
Bern
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Switzerland
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Binningen
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Switzerland
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Lausanne
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Switzerland
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Lugano
Country [147] 0 0
Switzerland
State/province [147] 0 0
Luzern
Country [148] 0 0
Switzerland
State/province [148] 0 0
Zürich
Country [149] 0 0
United Arab Emirates
State/province [149] 0 0
Abu dhabi
Country [150] 0 0
United Arab Emirates
State/province [150] 0 0
Dubai
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Bedford
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United Kingdom
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Belfast
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United Kingdom
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Birmingham
Country [154] 0 0
United Kingdom
State/province [154] 0 0
Bradford
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United Kingdom
State/province [155] 0 0
Bristol
Country [156] 0 0
United Kingdom
State/province [156] 0 0
Cardiff
Country [157] 0 0
United Kingdom
State/province [157] 0 0
Cheltenham
Country [158] 0 0
United Kingdom
State/province [158] 0 0
Colchester
Country [159] 0 0
United Kingdom
State/province [159] 0 0
Coventry
Country [160] 0 0
United Kingdom
State/province [160] 0 0
Frimley
Country [161] 0 0
United Kingdom
State/province [161] 0 0
Harrow
Country [162] 0 0
United Kingdom
State/province [162] 0 0
Hull
Country [163] 0 0
United Kingdom
State/province [163] 0 0
Leeds
Country [164] 0 0
United Kingdom
State/province [164] 0 0
Liverpool
Country [165] 0 0
United Kingdom
State/province [165] 0 0
London
Country [166] 0 0
United Kingdom
State/province [166] 0 0
Maidstone, Kent
Country [167] 0 0
United Kingdom
State/province [167] 0 0
Manchester
Country [168] 0 0
United Kingdom
State/province [168] 0 0
Newcastle upon Tyne
Country [169] 0 0
United Kingdom
State/province [169] 0 0
Norfolk
Country [170] 0 0
United Kingdom
State/province [170] 0 0
Oxford
Country [171] 0 0
United Kingdom
State/province [171] 0 0
Sheffield
Country [172] 0 0
United Kingdom
State/province [172] 0 0
Southampton
Country [173] 0 0
United Kingdom
State/province [173] 0 0
Sunderland
Country [174] 0 0
United Kingdom
State/province [174] 0 0
Torquay
Country [175] 0 0
United Kingdom
State/province [175] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: MR41927 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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.