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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
Date last updated
21/10/2024

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
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
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, 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
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
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
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, 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
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
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
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
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
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, 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
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
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
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
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
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
6000
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
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Norfolk
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Oxford
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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
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 in approved retinal indications (Faricimab for neovascular age-related macular degeneration \[nAMD\], diabetic macular edema \[DME\], and retinal vein occlusion; Port Delivery System with Ranibizumab for nAMD) 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/study/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
[email protected]
Contact person for scientific queries



Summary Results

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