Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, Diabetic Macular Edema, Hemi-retinal Vein Occlusion, Neovascular Age-related Macular Degeneration, Retinal Vein Occlusion
Conditions
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.
Interventions
DRUGFaricimab
Faricimab will be administered as per local clinical practice and local labeling.
COMBINATION_PRODUCTPort Delivery System with Ranibizumab
The port delivery system with ranibizumab will be administered as per local clinical practice and local labeling.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Argentina, Australia, Bulgaria, Canada, Chile, Croatia, Czechia, Denmark, Egypt, France, Germany, Hong Kong, Israel, Italy, Japan, Poland, Puerto Rico, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, United States
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed