A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products

Recruiting

• Conditions: Neovascular Age-related Macular Degeneration; Diabetic Macular Edema; Retinal Vein Occlusion; Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion; Hemi-retinal Vein Occlusion
• Interventions: Drug: Faricimab; Combination Product: Port Delivery System with Ranibizumab

• Registration Number: NCT05476926
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-25
• Study First Submitted QC: 2022-07-25
• Study First Posted: 2022-07-27
• Study Start: 2022-11-21
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-25
• Last Update Posted: 2025-07-28
• Primary Completion: 2026-12-31
• Study Completion: 2027-09-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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.

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 5: Faricimab for CRVO/HRVO	Faricimab	-
Cohort 3: Port Delivery System with Ranibizumab for nAMD	Port Delivery System with Ranibizumab	-
Cohort 4: Faricimab for BRVO	Faricimab	-
Cohort 1: Faricimab for nAMD	Faricimab	-
Cohort 2: Faricimab for DME	Faricimab	-

Primary Outcome Measures

Name	Time	Method
Change in Visual Acuity from Baseline at 1 Year, per Approved Retinal Indication and Product	Baseline and 1 year	Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.

Secondary Outcome Measures

Name	Time	Method
Change in Visual Acuity from Baseline Over Time, per Approved Retinal Indication and Product	Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)	Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other) Over Time, per Approved Retinal Indication and Product	Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)
Number of Treatments Over Time, per Approved Retinal Indication and Product	At 3, 6, and 12 months, and annually thereafter (up to 5 years)
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	From Baseline until end of study (up to 5 years)
Percentage of Eyes with Treatment Switch by Reason for Switch Over Time, per Approved Retinal Indication and Product	At 3, 6, and 12 months, and annually thereafter (up to 5 years)
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	At 3, 6, and 12 months, and annually thereafter (up to 5 years)
Total Number of Visits per Year, per Approved Retinal Indication and Product	Annually (up to 5 years)
Number of Visits With or Without Treatment per Year, per Approved Retinal Indication and Product	Annually (up to 5 years)
Time Interval Between Treatments per Year, per Approved Retinal Indication and Product	Annually (up to 5 years)
Number of Eyes Treated with Ocular Concomitant and Subsequent Medications by Type and Frequency During the Study, per Approved Retinal Indication and Product	From Baseline until end of study (up to 5 years)
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	Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)	Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
Change in Visual Acuity from Baseline Over Time, According to Number of Treatments, per Approved Retinal Indication and Product	Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)	Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
Change in Visual Acuity from Baseline Over Time, According to Total Number of Visits, per Approved Retinal Indication and Product	Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)	Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
Change in Visual Acuity from Baseline Over Time, According to Treatment Schedule, per Approved Retinal Indication and Product	Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)	Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
Change in Central Subfield Thickness (CST) from Baseline Over Time, per Approved Retinal Indication and Product	Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)
Number of Participants with at Least One Ocular Adverse Event, by Severity and Seriousness, per Approved Retinal Indication and Product	From Baseline until end of study (up to 5 years)	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.
Number of Participants with at Least One Non-Ocular Adverse Event, by Severity and Seriousness, per Approved Retinal Indication and Product	From Baseline until end of study (up to 5 years)	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.

Trial Locations

Locations (308)

Retinal Research Institute, LLC; 🇺🇸 Phoenix, Arizona, United States

Retina-Vitreous Associates Medical Group; 🇺🇸 Beverly Hills, California, United States

California Eye Specialists Medical group Inc.; 🇺🇸 Pasadena, California, United States

Retinal Consultants Medical Group; 🇺🇸 Sacramento, California, United States

Advanced Research; 🇺🇸 Coral Springs, Florida, United States

Retina Specialty Institute; 🇺🇸 Pensacola, Florida, United States

University Retina and Macula Associates, PC; 🇺🇸 Lemont, Illinois, United States

Springfield Clinic, Llp; 🇺🇸 Springfield, Illinois, United States

Retina Associates of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Cumberland Valley Retina Consultants PC; 🇺🇸 Hagerstown, Maryland, United States

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