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.
Study Type
OBSERVATIONAL
Enrollment
6,000
Faricimab will be administered as per local clinical practice and local labeling.
The port delivery system with ranibizumab will be administered as per local clinical practice and local labeling.
Retinal Research Institute, LLC
Phoenix, Arizona, 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
Change in Visual Acuity from Baseline at 1 Year, per Approved Retinal Indication and Product
Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
Time frame: Baseline and 1 year
Change in Visual Acuity from Baseline Over Time, per Approved Retinal Indication and Product
Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
Time frame: Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)
Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other) Over Time, per Approved Retinal Indication and Product
Time frame: Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)
Number of Treatments Over Time, per Approved Retinal Indication and Product
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Annually (up to 5 years)
Number of Visits With or Without Treatment per Year, per Approved Retinal Indication and Product
Time frame: Annually (up to 5 years)
Time Interval Between Treatments per Year, per Approved Retinal Indication and Product
Time frame: 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
Time frame: 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
Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
Time frame: Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)
Change in Visual Acuity from Baseline Over Time, According to Number of Treatments, per Approved Retinal Indication and Product
Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
Time frame: Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)
Change in Visual Acuity from Baseline Over Time, According to Total Number of Visits, per Approved Retinal Indication and Product
Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
Time frame: Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)
Change in Visual Acuity from Baseline Over Time, According to Treatment Schedule, per Approved Retinal Indication and Product
Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
Time frame: Baseline, 3, 6, and 12 months, and annually thereafter (up to 5 years)
Change in Central Subfield Thickness (CST) from Baseline Over Time, per Approved Retinal Indication and Product
Time frame: 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
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.
Time frame: From Baseline until end of study (up to 5 years)
Number of Participants with at Least One Non-Ocular Adverse Event, by Severity and Seriousness, per Approved Retinal Indication and Product
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.
Time frame: From Baseline until end of study (up to 5 years)
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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
Associated Retinal Consultants PC
Royal Oak, Michigan, United States
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