Active not recruitingOBSERVATIONAL

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

This study, called VOYAGER, is collecting information from patients in their everyday eye care. It's not a typical trial where new treatments are tested. Instead, it's about seeing how well existing eye medicines from Roche (like Faricimab and one used with a Port Delivery System) work over time for conditions such as wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusion. Researchers want to understand treatment choices and long-term effects. Taking part won't change your regular doctor's care or treatment plan; decisions about your treatment will always be made by your doctor, completely separate from your decision to join this study.

At a glance

Status

Active not recruiting

Sponsor

Hoffmann-La Roche

Enrolment target

6,000

Start

21 Nov 2022

Estimated completion

30 Nov 2027

Neovascular Age-related Macular Degeneration Diabetic Macular Edema Retinal Vein Occlusion Branch Retinal Vein Occlusion Central Retinal Vein Occlusion Hemi-retinal Vein Occlusion

What is this study about?

This study, called VOYAGER, is a bit different from what you might usually think of as a clinical trial. Instead of testing a new medicine or giving patients a specific treatment plan, it's designed to learn from peoples' real-life experiences. Think of it like gathering information on how certain eye medicines are actually used and how well they work for patients with specific eye conditions in their normal visits to the eye doctor.

The main goal is to understand the long-term effects, both good and bad, of Roche's eye medicines, Faricimab and the Port Delivery System with Ranibizumab. These medicines are used for serious eye conditions like wet age-related macular degeneration (nAMD), diabetic macular edema (DME), and different types of retinal vein occlusion (RVO). The study wants to see how these treatments perform over a longer period, what doctors consider when choosing these treatments, and how patients' vision changes. Importantly, this study won't ask you to do anything different from your usual care; your doctor will continue to make all decisions about your treatment.

By gathering this 'real-world' information from many different patients across various countries, the researchers hope to gain a much deeper insight into these eye conditions and their treatments. This kind of study helps us understand how medicines work for a wider range of people than just those in highly controlled trials. The knowledge gained could help improve future understanding and care for people with these conditions, without directly changing your personal treatment.

Key takeaways

This study collects real-world information about existing eye medicines.
It helps researchers understand long-term effects and treatment choices.
Your medical care and treatment will not change if you participate.
Only approved Roche eye medicines for specific conditions are being observed.
Participation is entirely voluntary, and you can withdraw at any time.
The information helps improve future understanding of eye conditions and treatments.

Who may be eligible?

To be part of this study, you need to be an adult, as defined by local UK rules. You generally fit if you are either starting a specific approved Roche eye medicine for the first time (or started it very recently) for conditions like wet macular degeneration or diabetic eye swelling, as decided by your eye doctor.

Another way you might be eligible is if you've already been part of a Roche study that involved an eye medicine for one of these conditions, and you are now continuing to receive that same approved treatment.

You cannot join this study if you are currently taking part in another eye-related medical study that involves receiving a new medicine or a special procedure. However, if you are simply continuing treatment with a Roche medicine after a previous Roche study, that's usually okay.

Quick self-check

Am I an adult over 18 years old?
Am I starting (or recently started) a specific approved Roche eye medicine for conditions like wet macular degeneration or diabetic eye swelling, as decided by my doctor?
Or, have I previously been in a Roche study for these eye conditions and am now continuing that same approved treatment?
Am I NOT currently taking part in another eye-related study that involves a new medicine or procedure?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, it's important to understand that it won't change your regular eye care. You will continue to have your appointments and receive your treatment exactly as your eye doctor would normally recommend. The study will simply involve your doctor sharing information about your eye condition, your treatment, and how you're doing over time with the researchers. There are no extra visits, assessments, or medications specifically for this study. The total duration of your participation will depend on how long your doctor continues to treat you with the specified medicine and how long the study continues to collect data, but it won't lead to changes in your treatment plan. You'll continue to receive care as usual.

Potential risks and benefits

Participating in this study offers no direct medical benefit to you, as it doesn't change your treatment or provide new interventions. However, the information gathered from your real-world experience, along with that of many others, can help improve the understanding of these eye conditions and their treatments for future patients. There are no additional risks linked to participating in this study beyond the usual risks associated with your routine medical care and the medications you are already receiving. You are always free to change your mind and withdraw from the study at any time without it affecting your medical care in any way.

Locations (299)

Retinal Research Institute, LLC
Phoenix, United States
California Eye Specialists Medical group Inc.
Pasadena, United States
Retinal Consultants Medical Group
Sacramento, United States
Advanced Research
Coral Springs, United States
Retina Specialty Institute
Pensacola, United States
University Retina and Macula Associates, PC
Lemont, United States
Springfield Clinic, Llp
Springfield, United States
Retina Associates of Kentucky
Lexington, United States
Cumberland Valley Retina Consultants PC
Hagerstown, United States
Associated Retinal Consultants PC
Royal Oak, United States
Erie Retinal Surgery
Erie, United States
Tennessee Retina PC
Nashville, United States

+287 more sites — see the official record for the full list.

Common questions

Will my treatment change if I join this study?

No, absolutely not. Your doctor will continue to make all decisions about your treatment, completely separate from this study. Your care will remain the same.

What kind of information will be collected about me?

The study will collect information about your eye condition, the specific Roche eye medicine you're receiving, how long you've been on it, and how your vision is responding. This is all information your doctor would normally keep track of.

Is this a clinical trial where I might get a new or untested medicine?

No, this is not a trial testing new medicines. It's a 'real-world' study, meaning it looks at how approved medicines work in patients under normal care. You will receive the treatment your doctor has already prescribed.

How long will I be in the study?

The study collects long-term information. Your participation typically continues as long as you are receiving the specified treatment from your doctor and the study is ongoing. However, you can stop participating at any time.

Will my personal details be kept private?

Yes, your privacy is very important. All information shared with the study will be anonymised or de-identified, meaning your name and other identifying details won't be linked to the data.