Ranibizumab + Faricimab for Macular Degeneration
(VOYAGER Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to gather real-world data on the performance of certain Roche eye treatments over time for conditions like neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion. It examines the effectiveness and safety of Faricimab (Vabysmo) and the Port Delivery System with Ranibizumab (Susvimo) in everyday medical practice. The trial includes individuals who have recently started or are continuing these treatments for their eye condition. Participants' usual care remains unchanged, and the trial does not provide medical advice or influence their treatment plan. As a Phase 4 trial, this research helps to understand how these FDA-approved treatments benefit more patients in real-world settings.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. It mentions that treatment decisions are made by your doctor and won't change your standard care.
What is the safety track record for these treatments?
Research has shown that Faricimab is generally safe for individuals with eye conditions such as diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD). Some individuals might experience blurry vision immediately after an eye injection, but this typically resolves quickly. It is important to avoid driving or operating machinery until vision returns to normal.
For the Port Delivery System with Ranibizumab, studies conducted over several years have found it to be well-tolerated for treating nAMD. This system consistently improves vision and requires fewer treatments compared to monthly injections. Side effects are usually mild and manageable.
Long-term studies have tested these treatments, demonstrating their safety as options for managing these eye conditions.12345Why are researchers excited about this trial?
Researchers are excited about these treatments because Faricimab and the Port Delivery System with Ranibizumab offer innovative approaches for tackling eye conditions. Unlike standard treatments for conditions like nAMD, DME, CRVO/HRVO, and BRVO, which often involve frequent eye injections, Faricimab targets two pathways—angiopoietin-2 and VEGF-A—potentially leading to longer-lasting effects and fewer injections. The Port Delivery System with Ranibizumab provides a novel approach by continuously delivering medication over several months through a small, refillable implant, reducing the need for regular injections. These advancements could significantly improve patient convenience and outcomes by minimizing treatment burden and enhancing long-term vision preservation.
What evidence suggests that this trial's treatments could be effective for retinal conditions?
Research shows that Faricimab, which participants in this trial may receive, effectively treats several eye conditions. For retinal vein occlusion, studies indicate that Faricimab can improve vision and reduce retinal swelling over 72 weeks. In cases of neovascular age-related macular degeneration (nAMD), Faricimab has proven to be safe and effective, offering lasting improvements in vision. For diabetic macular edema (DME), Faricimab has enhanced vision and decreased retinal swelling over two years. Another treatment option in this trial is the Port Delivery System with Ranibizumab for nAMD, which demonstrated long-term disease control, with many patients maintaining good vision for up to five years. These findings suggest that these treatments could effectively manage these conditions over the long term.678910
Who Is on the Research Team?
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Data Collection
Collection of real-world, long-term data to explore effectiveness, safety, and treatment patterns
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Faricimab
- Port Delivery System with Ranibizumab
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University
Citations
New long-term data for Roche's Vabysmo show sustained ...
The sustained vision improvements and retinal drying seen up to 72 weeks reaffirm Vabysmo as an effective treatment for retinal vein occlusion.
Short-term real-world effectiveness of faricimab on macular ...
These findings validated the real-world efficacy of faricimab and supported its use as a viable therapeutic agent. Keywords: PRN, Retinal vein ...
Study Design in RVO | VABYSMO® (faricimab-svoa)
Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of VABYSMO.
NCT04740905 | A Study to Evaluate the Efficacy and ...
This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and ...
Faricimab for retinal vein occlusion: a review of current ...
The trial results showed that after receiving Faricimab every 4 weeks for up to 24 weeks, patients in the Faricimab group experienced more ...
Clinical Review - Faricimab (Vabysmo) - NCBI - NIH
Clinical studies have shown robust efficacy and safety for frequent (e.g., monthly or bimonthly) anti-VEGF injections for the treatment of DME.- The results ...
Vision Data in nAMD | VABYSMO® (faricimab-svoa)
Learn about the vision data for VABYSMO® (faricimab-svoa) in nAMD. See full safety for more information.
VABYSMO® (faricimab-svoa) Important Safety Information ...
Your vision may be impaired after receiving an eye injection or after an eye exam. Do not drive or use machinery until your vision has recovered ...
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remedypublications.com
remedypublications.com/open-access/the-efficacy-and-safety-of-faricimab-for-the-treatment-of-9933.pdfthe-efficacy-and-safety-of-faricimab-for-the-treatment- ...
Unclear risk mainly focused on blinding of outcome assignments, other risk included incomplete data outcomes and assignment concealment and the ...
NCT03038880 | Study to Evaluate Faricimab (RO6867461; ...
52-week study to investigate the efficacy, safety and pharmacokinetics of faricimab (RO6867461; RG7716) administered with extended dosing regimens in treatment ...
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