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

Study Overview
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Brief Summary
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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. The study start in a country is contingent on the approval of at least one product.

Official Title
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Real-World, Long-Term Data Collection to Gain Clinical Insights Into Roche Ophthalmology Products (VOYAGER STUDY)

Conditions
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Neovascular Age-related Macular Degeneration, Diabetic Macular Edema

Intervention / Treatment
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* Drug: Faricimab
* Combination Product: Port Delivery System with Ranibizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have provided informed consent, as required per local regulations Adult patients, as defined by local regulations and local product label, who are being treated with any approved Roche ophthalmology product in retinal indication in scope for this study, according to the investigator's discretion in routine clinical practice (irrespective of whether the patient is starting treatment at the time of enrollment or is already receiving treatment). Patients are also considered eligible if they are rolling over from Roche interventional studies and continuing treatment with any specified approved Roche ophthalmology product in retinal indication in scope for this study Exclusion Criteria: Concomitant participation 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 in scope for this study)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Faricimab for nAMD<br> | Drug: Faricimab<br>* Faricimab will be administered as per local clinical practice and local labeling.<br>* Other names: RG7716;|
| Faricimab for DME<br> | Drug: Faricimab<br>* Faricimab will be administered as per local clinical practice and local labeling.<br>* Other names: RG7716;|
| Port Delivery System with Ranibizumab for nAMD<br> | Combination Product: Port Delivery System with Ranibizumab<br>* The port delivery system with ranibizumab will be administered as per local clinical practice and local labeling.<br>* Other names: RG6321;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Acuity per Eye 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. | Baseline and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Acuity per Eye 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. | Baseline, 3 and 6 months, and 2, 3, 4, and 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 |  | Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years | 
| Number of Treatments per Year, per Approved Retinal Indication and Product |  | 1, 2, 3, 4, and 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 and 6 months, and 1, 2, 3, 4, and 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 and 6 months, and 1, 2, 3, 4, and 5 years | 
| Total Number of Visits per Year, per Approved Retinal Indication and Product |  | 1, 2, 3, 4, and 5 years | 
| Number of Visits With or Without Treatment per Year, per Approved Retinal Indication and Product |  | 1, 2, 3, 4, and 5 years | 
| Time Interval Between Treatments per Year, per Approved Retinal Indication and Product |  | 1, 2, 3, 4, and 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 per Eye 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. | Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years | 
| Change in Visual Acuity per Eye 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. | Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years | 
| Change in Visual Acuity per Eye 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. | Baseline, 3 and 6 months, and 1, 2, 3, 4, and 5 years | 
| Change in Visual Acuity per Eye 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. | Baseline, 3 and 6 months, and 1, 2, 3, 4, and 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. | 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. | From Baseline until end of study (up to 5 years) |