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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05476926




Registration number
NCT05476926
Ethics application status
Date submitted
25/07/2022
Date registered
27/07/2022
Date last updated
4/06/2024

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
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Faricimab
Combination Product - 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.

Combination Product: 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
Combination Product
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
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
Timepoint [1] 0 0
Baseline, 3 and 6 months, and 2, 3, 4, and 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
Timepoint [2] 0 0
Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years
Secondary outcome [3] 0 0
Number of Treatments per Year, per Approved Retinal Indication and Product
Timepoint [3] 0 0
1, 2, 3, 4, and 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
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
Timepoint [5] 0 0
At 3 and 6 months, and 1, 2, 3, 4, and 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
Timepoint [6] 0 0
At 3 and 6 months, and 1, 2, 3, 4, and 5 years
Secondary outcome [7] 0 0
Total Number of Visits per Year, per Approved Retinal Indication and Product
Timepoint [7] 0 0
1, 2, 3, 4, and 5 years
Secondary outcome [8] 0 0
Number of Visits With or Without Treatment per Year, per Approved Retinal Indication and Product
Timepoint [8] 0 0
1, 2, 3, 4, and 5 years
Secondary outcome [9] 0 0
Time Interval Between Treatments per Year, per Approved Retinal Indication and Product
Timepoint [9] 0 0
1, 2, 3, 4, and 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
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
Timepoint [11] 0 0
Baseline, 3 and 6 months, and 1, 2, 3, 4, and 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
Timepoint [12] 0 0
Baseline, 3 and 6 months, and 1, 2, 3, 4, and 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
Timepoint [13] 0 0
Baseline, 3 and 6 months, and 1, 2, 3, 4, and 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
Timepoint [14] 0 0
Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years
Secondary outcome [15] 0 0
Change in Central Subfield Thickness (CST) from Baseline Over Time, per Approved Retinal Indication and Product
Timepoint [15] 0 0
Baseline, 3 and 6 months, and 1, 2, 3, 4, and 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
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
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
21/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
5000
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
Sunshine Coast University Hospital - Geebung
Recruitment hospital [3] 0 0
Cabrini Hospital Malvern - Malvern
Recruitment hospital [4] 0 0
Lions Outback Vision Service in Broome - Broome
Recruitment postcode(s) [1] 0 0
2220 - Hurstville
Recruitment postcode(s) [2] 0 0
4034 - Geebung
Recruitment postcode(s) [3] 0 0
3144 - Malvern
Recruitment postcode(s) [4] 0 0
6725 - Broome
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
Bulgaria
State/province [15] 0 0
Sofia
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Varna
Country [17] 0 0
Canada
State/province [17] 0 0
British Columbia
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Chile
State/province [20] 0 0
Las Condes
Country [21] 0 0
Chile
State/province [21] 0 0
Vitacura
Country [22] 0 0
Croatia
State/province [22] 0 0
Osijek
Country [23] 0 0
Croatia
State/province [23] 0 0
Zagreb
Country [24] 0 0
Czechia
State/province [24] 0 0
Praha 6
Country [25] 0 0
France
State/province [25] 0 0
Bordeaux Floirac
Country [26] 0 0
France
State/province [26] 0 0
Bordeaux
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France
State/province [27] 0 0
Creteil cedex
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France
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Dijon Cedex
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France
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Ecully
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France
State/province [30] 0 0
La Rochelle cedex
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France
State/province [31] 0 0
Le Chesnay Cedex
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France
State/province [32] 0 0
Lille
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France
State/province [33] 0 0
Lyon
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France
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Marseille
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France
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Montargis
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France
State/province [36] 0 0
Montauban
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France
State/province [37] 0 0
Montpellier
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France
State/province [38] 0 0
Nantes cedex 1
Country [39] 0 0
France
State/province [39] 0 0
Nantes
Country [40] 0 0
France
State/province [40] 0 0
Nice
Country [41] 0 0
France
State/province [41] 0 0
Paris
Country [42] 0 0
France
State/province [42] 0 0
Saint Etienne
Country [43] 0 0
France
State/province [43] 0 0
St Cyr Sur Loire
Country [44] 0 0
France
State/province [44] 0 0
St Herblain
Country [45] 0 0
France
State/province [45] 0 0
Toulouse
Country [46] 0 0
Germany
State/province [46] 0 0
Berlin
Country [47] 0 0
Germany
State/province [47] 0 0
Chemnitz
Country [48] 0 0
Germany
State/province [48] 0 0
Dresden
Country [49] 0 0
Germany
State/province [49] 0 0
Frankfurt
Country [50] 0 0
Germany
State/province [50] 0 0
Greifswald
Country [51] 0 0
Germany
State/province [51] 0 0
Hannover
Country [52] 0 0
Germany
State/province [52] 0 0
Heidelberg
Country [53] 0 0
Germany
State/province [53] 0 0
Leipzig
Country [54] 0 0
Germany
State/province [54] 0 0
Ludwigshafen
Country [55] 0 0
Germany
State/province [55] 0 0
Magdeburg
Country [56] 0 0
Germany
State/province [56] 0 0
Mannheim
Country [57] 0 0
Germany
State/province [57] 0 0
Rostock
Country [58] 0 0
Israel
State/province [58] 0 0
Haifa
Country [59] 0 0
Israel
State/province [59] 0 0
Jerusalem
Country [60] 0 0
Italy
State/province [60] 0 0
Calabria
Country [61] 0 0
Italy
State/province [61] 0 0
Campania
Country [62] 0 0
Italy
State/province [62] 0 0
Friuli-Venezia Giulia
Country [63] 0 0
Italy
State/province [63] 0 0
Lazio
Country [64] 0 0
Italy
State/province [64] 0 0
Liguria
Country [65] 0 0
Italy
State/province [65] 0 0
Lombardia
Country [66] 0 0
Italy
State/province [66] 0 0
Piemonte
Country [67] 0 0
Italy
State/province [67] 0 0
Sardegna
Country [68] 0 0
Italy
State/province [68] 0 0
Sicilia
Country [69] 0 0
Japan
State/province [69] 0 0
Aichi
Country [70] 0 0
Japan
State/province [70] 0 0
Chiba
Country [71] 0 0
Japan
State/province [71] 0 0
Chuo-shi
Country [72] 0 0
Japan
State/province [72] 0 0
Fukuoka
Country [73] 0 0
Japan
State/province [73] 0 0
Gifu
Country [74] 0 0
Japan
State/province [74] 0 0
Hiroshima
Country [75] 0 0
Japan
State/province [75] 0 0
Hokkaido
Country [76] 0 0
Japan
State/province [76] 0 0
Hyogo
Country [77] 0 0
Japan
State/province [77] 0 0
Ibaraki
Country [78] 0 0
Japan
State/province [78] 0 0
Kagawa
Country [79] 0 0
Japan
State/province [79] 0 0
Kanagawa
Country [80] 0 0
Japan
State/province [80] 0 0
Meguro-ku
Country [81] 0 0
Japan
State/province [81] 0 0
Mie
Country [82] 0 0
Japan
State/province [82] 0 0
Nagano
Country [83] 0 0
Japan
State/province [83] 0 0
Nagasaki
Country [84] 0 0
Japan
State/province [84] 0 0
Osaka-shi
Country [85] 0 0
Japan
State/province [85] 0 0
Osaka
Country [86] 0 0
Japan
State/province [86] 0 0
Saitama
Country [87] 0 0
Japan
State/province [87] 0 0
Shiga
Country [88] 0 0
Japan
State/province [88] 0 0
Suita
Country [89] 0 0
Japan
State/province [89] 0 0
Takatsuki-shi
Country [90] 0 0
Japan
State/province [90] 0 0
Tokushima
Country [91] 0 0
Japan
State/province [91] 0 0
Tokyo
Country [92] 0 0
Japan
State/province [92] 0 0
Yamaguchi
Country [93] 0 0
Japan
State/province [93] 0 0
Yoshida-gun
Country [94] 0 0
Puerto Rico
State/province [94] 0 0
Arecibo
Country [95] 0 0
Singapore
State/province [95] 0 0
Singapore
Country [96] 0 0
Spain
State/province [96] 0 0
LA Coruña
Country [97] 0 0
Spain
State/province [97] 0 0
Madrid
Country [98] 0 0
Spain
State/province [98] 0 0
Vizcaya
Country [99] 0 0
Spain
State/province [99] 0 0
Barcelona
Country [100] 0 0
Spain
State/province [100] 0 0
Burgos
Country [101] 0 0
Spain
State/province [101] 0 0
Malaga
Country [102] 0 0
Spain
State/province [102] 0 0
Murcia
Country [103] 0 0
Spain
State/province [103] 0 0
Valladolid
Country [104] 0 0
Switzerland
State/province [104] 0 0
Aarau
Country [105] 0 0
Switzerland
State/province [105] 0 0
Bern
Country [106] 0 0
Switzerland
State/province [106] 0 0
Binningen
Country [107] 0 0
Switzerland
State/province [107] 0 0
Lausanne
Country [108] 0 0
Switzerland
State/province [108] 0 0
Lugano
Country [109] 0 0
Switzerland
State/province [109] 0 0
Luzern
Country [110] 0 0
Switzerland
State/province [110] 0 0
Zürich
Country [111] 0 0
United Arab Emirates
State/province [111] 0 0
Abu dhabi
Country [112] 0 0
United Arab Emirates
State/province [112] 0 0
Dubai
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Bedford
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Belfast
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Birmingham
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Bradford
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Bristol
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Cardiff
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Cheltenham
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Colchester
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Coventry
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Frimley
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Harrow
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Hull
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Leeds
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Liverpool
Country [127] 0 0
United Kingdom
State/province [127] 0 0
London
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Maidstone, Kent
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Manchester
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Newcastle upon Tyne
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Norfolk
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Oxford
Country [133] 0 0
United Kingdom
State/province [133] 0 0
Sheffield
Country [134] 0 0
United Kingdom
State/province [134] 0 0
Southampton
Country [135] 0 0
United Kingdom
State/province [135] 0 0
Sunderland
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Torquay

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05476926
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 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)
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05476926