A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products (NCT05476926) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products
United States, Argentina, Australia6,000 participantsStarted 2022-11-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is described as 'real-world' rather than a standard clinical trial — does that mean it's mainly observing how Roche eye treatments already work in practice, rather than testing something new, and how would that affect what I might get out of participating?
2Since the study is actively running but no longer enrolling new participants, is there any chance I could still be considered, or should we focus entirely on other treatment options available to me right now?
3The study is tracking changes in visual acuity over one year across conditions like wet AMD, diabetic macular edema, and retinal vein occlusion — given my specific diagnosis, would the standard approved treatment for my condition be the same as what's being observed in this study anyway?
4Because this is listed as 'Phase NA,' meaning it's an observational study rather than a controlled trial, what does that mean for how confident my doctor can be about the safety and effectiveness data it's likely to produce?
5Are there other ongoing studies or standard-of-care treatments for my retinal condition that my doctor thinks I should be considering alongside or instead of something like this observational registry?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Visual Acuity from Baseline at 1 Year, per Approved Retinal Indication and Product