Ranibizumab + Faricimab for Macular Degeneration

(VOYAGER Trial)

Recruiting at 415 trial locations

Overseen By Reference Study ID Number: MR41927 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hoffmann-La Roche

Must be taking: Roche ophthalmology products

Disqualifiers: Investigational drug or procedure

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

6000 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{6 7 8 9 10}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Have provided informed consent, as required per local regulations

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Collection of real-world, long-term data to explore effectiveness, safety, and treatment patterns

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Faricimab
• Port Delivery System with Ranibizumab

How Is the Trial Designed?

Group I: Cohort 5: Faricimab for CRVO/HRVO Experimental Treatment 1 Intervention

Group II: Cohort 4: Faricimab for BRVO Experimental Treatment 1 Intervention

Group III: Cohort 3: Port Delivery System with Ranibizumab for nAMD Experimental Treatment 1 Intervention

Group IV: Cohort 2: Faricimab for DME Experimental Treatment 1 Intervention

Group V: Cohort 1: Faricimab for nAMD Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

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

1. roche.com roche.com/media/releases/med-cor-2024-02-01b

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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12261859/

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 ...

3. vabysmo-hcp.com vabysmo-hcp.com/efficacy/study-design-rvo.html

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.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04740905

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 ...

5. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1646806/full

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 ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK601678/

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 ...

7. vabysmo-hcp.com vabysmo-hcp.com/efficacy/vision-namd.html

Vision Data in nAMD | VABYSMO® (faricimab-svoa) Learn about the vision data for VABYSMO® (faricimab-svoa) in nAMD. See full safety for more information.

8. vabysmo.com vabysmo.com/dme/safety/important-safety-information.html

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 ...

9. remedypublications.com remedypublications.com/open-access/the-efficacy-and-safety-of-faricimab-for-the-treatment-of-9933.pdf

the-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 ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT03038880

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 ...