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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
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
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.
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
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
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
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Arizona
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United States of America
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California
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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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Maryland
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Michigan
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Ciudad Autonoma de Buenos Aires
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Argentina
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Cordoba
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Argentina
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San Miguel de Tucuman
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Bulgaria
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Sofia
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Varna
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British Columbia
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Osijek
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Montpellier
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Nantes
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Nice
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Osny
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Saint Etienne
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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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Dessau - Roßlau
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Dresden
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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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Leipzig
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Ludwigshafen
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Magdeburg
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Mannheim
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München
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Rostock
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Sulzbach
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Würzburg
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Holon
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Puglia
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Sardegna
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Sicilia
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Veneto
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Aichi
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Chiba
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Chuo-shi
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Fukuoka
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Gifu
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Ibaraki
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Kagawa
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Kanagawa
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Meguro-ku
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Mie
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Osaka
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Tokyo
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Toyoake-shi
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Yamaguchi
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Yoshida-gun
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Puerto Rico
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Barcelona
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Bern
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Binningen
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Zürich
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Dubai
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United Kingdom
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Bedford
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Belfast
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Birmingham
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Bradford
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Bristol
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Cardiff
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Cheltenham
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Colchester
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Coventry
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Frimley
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Harrow
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Hull
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Leeds
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Liverpool
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London
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United Kingdom
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Maidstone, Kent
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United Kingdom
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Manchester
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
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Norfolk
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United Kingdom
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Oxford
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Sheffield
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Southampton
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Sunderland
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Torquay
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United Kingdom
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Wolverhampton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
[email protected]
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.


Results not provided in https://clinicaltrials.gov/study/NCT05476926