Faricimab Schedules for Age-Related Macular Degeneration

(AO Trial)

Recruiting at 60 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Jaeb Center for Health Research

Must not be taking: Anti-VEGF, Corticosteroids

Disqualifiers: Dense cataract, Pathologic myopia, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods of using the drug faricimab (also known as Vabysmo) to treat neovascular age-related macular degeneration (AMD), which affects vision. One method follows a "treat and extend" schedule, while the other uses home monitoring technology to guide treatment. The goal is to determine which approach more effectively manages the condition. Individuals who have not yet received treatment for their AMD and can commit to daily home eye scans for two years may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have received certain eye treatments like intravitreal injections or corticosteroids recently, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that faricimab is generally safe for people. In studies, participants received faricimab through eye injections to treat neovascular age-related macular degeneration, the focus of this trial. These studies found that faricimab usually causes mild side effects, such as temporary eye discomfort, with serious side effects being rare.

The FDA has approved faricimab for treating certain eye conditions, indicating it is considered safe. This approval means it has passed safety tests for other uses, although individual experiences can differ. Prospective participants can take comfort in knowing that faricimab has been studied and used in similar ways before. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments for age-related macular degeneration?

Researchers are excited about faricimab for age-related macular degeneration because it offers a new way to manage this eye condition. Unlike current treatments like ranibizumab and aflibercept, which target a single pathway, faricimab simultaneously targets two pathways involved in vision loss. Additionally, its unique delivery schedules, such as the "Treat and Extend" and "Home OCT-guided treatment," aim to extend the time between injections, potentially reducing treatment burden for patients. This dual-action approach and flexible dosing could lead to improved outcomes and more convenience for those affected by this condition.

What evidence suggests that this trial's treatments could be effective for age-related macular degeneration?

Research has shown that faricimab can improve vision in people with neovascular age-related macular degeneration (AMD). In studies, patients receiving faricimab experienced better vision with fewer treatments compared to traditional methods. Faricimab targets two causes of vision loss, potentially reducing eye swelling and slowing the disease. This trial will evaluate faricimab administered in two schedules: "Treat and Extend" and "Home Optical Coherence Tomography-Guided Treatment." These findings suggest that faricimab is a promising option for treating this type of AMD. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for people over 50 with neovascular age-related macular degeneration (AMD) who haven't been treated before. Participants must be able to consent, use a home OCT device independently, and commit to daily monitoring tests for 2 years. They should have some vision left (20/320 or better) and AMD-related changes in the eye.

Inclusion Criteria

I have a certain type of eye condition affecting my vision.

I can use the Home OCT device by myself for a scanning session.

I have macular degeneration with specific complications affecting the center of my vision.

Exclusion Criteria

I have had eye injections or laser treatment for eye conditions.

I have received eye injections for macular degeneration before.

I have not had eye injections with steroids in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Run-in

Eligible study eyes receive a baseline intravitreal faricimab injection and are assessed for scan quality

1 month

1 visit (in-person)

Randomization and Treatment

Participants are randomized into Treat and Extend or Home OCT-guided treatment groups, with follow-up visits every 4-18 weeks for T&E group and daily self-scans for Home OCT group

104 weeks

Variable visits (in-person) for T&E group, as needed for Home OCT group

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary outcomes measured at 52 and 104 weeks

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Faricimab

Trial Overview The study compares two ways of using faricimab injections for AMD: one group follows a Treat and Extend schedule at the clinic, while the other uses home OCT scans to decide when treatments are needed.

How Is the Trial Designed?

Group I: Treat and Extend Experimental Treatment 1 Intervention

Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule

Group II: Home optical coherence tomography-Guided Treatment Experimental Treatment 1 Intervention

Intravitreal injections of 6 mg faricimab on a Home OCT-guided treatment schedule

Faricimab is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Vabysmo for:

• Neovascular age-related macular degeneration (nAMD)
• Diabetic macular edema (DME)
• Macular edema following retinal vein occlusion (RVO)

Approved in European Union as Vabysmo for:

• Neovascular age-related macular degeneration (nAMD)
• Diabetic macular edema (DME)

Approved in Canada as Vabysmo for:

• Neovascular age-related macular degeneration (nAMD)
• Diabetic macular edema (DME)

Who Is Running the Clinical Trial?

Jaeb Center for Health Research

Lead Sponsor

Trials

162

Recruited

36,200+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Juvenile Diabetes Research Foundation

Collaborator

Trials

237

Recruited

142,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Machine learning models developed from baseline characteristics and SD-OCT images showed promise in predicting treatment outcomes for patients with neovascular age-related macular degeneration (nAMD) receiving faricimab, with the best regression model achieving an R2 of 0.31 for visual acuity outcomes.

The study found that baseline visual acuity and central subfield thickness were the most influential factors in predicting treatment outcomes, but the overall predictive benefit of baseline imaging data remains uncertain, indicating a need for further validation with larger datasets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Machine Learning to Predict Faricimab Treatment Outcome in Neovascular Age-Related Macular Degeneration. Kikuchi, Y., Kawczynski, MG., Anegondi, N., et al.[2023]

In a study of 40 eyes from 38 patients with treatment-naïve neovascular age-related macular degeneration (nAMD), three monthly intravitreal injections of faricimab significantly improved best-corrected visual acuity (BCVA) and reduced foveal thickness after 16 weeks.

The treatment was generally safe, with 79.5% of eyes achieving a dry macula and a notable regression of polypoidal lesions in 61.1% of affected eyes, although one case of vitritis occurred without visual loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term outcomes of intravitreal faricimab for treatment-naïve neovascular age-related macular degeneration. Matsumoto, H., Hoshino, J., Nakamura, K., et al.[2023]

Faricimab is a bispecific antibody that targets both VEGF-A and Ang-2, and it has been approved in the USA for treating neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).

The drug is administered via intravitreal injection and is currently undergoing Phase III clinical trials for additional retinal vascular diseases, indicating its potential for broader therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Faricimab: First Approval. Shirley, M.[2022]

In a study of 376 patients with neovascular age-related macular degeneration (nAMD) treated with faricimab, significant improvements in best-corrected visual acuity (BCVA) and reductions in central subfield thickness (CST) were observed after one and three injections, indicating its efficacy in enhancing vision and reducing retinal fluid.

Faricimab was well-tolerated, with only a low incidence of treatable adverse events, such as one case of intraocular inflammation and one case of infectious endophthalmitis, suggesting it is a safe option for patients with nAMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The real-world efficacy and safety of faricimab in neovascular age-related macular degeneration: the TRUCKEE study - 6 month results. Khanani, AM., Aziz, AA., Khan, H., et al.[2023]

In a study involving treatment-naïve patients with neovascular age-related macular degeneration (nAMD), faricimab demonstrated similar improvements in best-corrected visual acuity (BCVA) compared to aflibercept, with mean gains of 7.1 letters for faricimab and 7.2 letters for aflibercept in Asian patients.

Faricimab was well tolerated and showed sustained visual and anatomical benefits, with a higher percentage of Asian patients achieving less frequent dosing (59.6% at Q16W) compared to non-Asian patients, indicating its efficacy and safety across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, durability, and safety of faricimab in patients from Asian countries with neovascular age-related macular degeneration: 1-Year subgroup analysis of the TENAYA and LUCERNE trials. Takahashi, K., Cheung, CMG., Iida, T., et al.[2023]

The phase III BALATON/COMINO trials will assess the efficacy and safety of faricimab in treating diabetic macular edema due to retinal vein occlusion, involving 1282 patients across 22 countries.

Faricimab is being compared to aflibercept using a personalized treatment approach that adjusts dosing intervals based on individual patient responses, aiming to demonstrate noninferiority in visual acuity outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BALATON and COMINO: Phase III Randomized Clinical Trials of Faricimab for Retinal Vein Occlusion: Study Design and Rationale. Hattenbach, LO., Abreu, F., Arrisi, P., et al.[2023]

In a study of 26 patients with neovascular age-related macular degeneration (nAMD), switching to intravitreal faricimab resulted in a significantly longer fluid-free interval compared to previous treatments with anti-VEGF agents, indicating improved efficacy.

No serious adverse events were reported, suggesting that faricimab is a safe option for patients who did not respond well to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravitreal faricimab for neovascular age-related macular degeneration previously treated with traditional anti-VEGF compounds: a real-world prospective study. Grimaldi, G., Cancian, G., Rizzato, A., et al.[2023]

Faricimab treatment in patients with neovascular age-related macular degeneration (nAMD) who did not respond to other anti-VEGF therapies resulted in significant anatomical improvements, including a reduction in central subfield thickness (CST) by 18µm and intraretinal/subretinal fluid height by 89µm after switching from previous treatments.

Despite the anatomical improvements, visual acuity remained stable after switching to faricimab, indicating that while the treatment effectively reduces fluid and swelling, it does not negatively impact vision in this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Faricimab Effectively Resolves Intraretinal Fluid and Preserves Vision in Refractory, Recalcitrant, and Nonresponsive Neovascular Age-Related Macular Degeneration. Cheng, AM., Joshi, S., Banoub, RG., et al.[2023]

A significant portion of the real-world population with neovascular age-related macular degeneration (nAMD) is eligible for the TENAYA and LUCERNE trials, with 86% of treatment-naïve individuals meeting the criteria.

The eligible patients from the Swedish Macula Registry were generally older and had worse visual acuity compared to trial participants, indicating that real-world patients may differ in characteristics from those in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eligibility for faricimab in a real-world neovascular age-related macular degeneration population: a cross-sectional study. Jern, I., Forsell, S., Norberg, H.[2022]

Citations

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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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11584429/

Faricimab for neovascular age-related macular degeneration ... Faricimab for neovascular age-related macular degeneration and diabetic macular edema: from preclinical studies to phase 3 outcomes

3. forpatients.roche.com forpatients.roche.com/content/patient-platform/global/en/trials/eye-disorder/amd/study-to-evaluate-ro6867461--rg7716--for-extended-durability-in-.pdf

Study to Evaluate Faricimab (RO6867461; RG7716) for ... This was a Phase II, multicenter, randomized, active comparator-controlled, 52-week study to investigate the efficacy, safety and pharmacokinetics of ...

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

Clinical Review - Faricimab (Vabysmo) - NCBI - NIH The clinician group noted that clinically meaningful outcomes include improvement in vision, reduction or resolution of macular edema, regression in Diabetic ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02484690

NCT02484690 | A Proof-of-Concept Study of Faricimab ... 36-week study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of faricimab (RO6867461) in participants with choroidal neovascularization ...

6. xoma.com xoma.com/royaltyportfolio/faricimab/

VABYSMO® (faricimab-svoa) - Clinical Trials Study to Evaluate Faricimab (RO6867461; RG7716) for Extended Durability in the Treatment of Neovascular Age Related Macular Degeneration · Switching to ...

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Efficacy and safety of faricimab for neovascular age-related ... ... , Neovascular Age-Related Macular Degeneration Treatment Trial Using B. Bevacizumab for neovascular age-related macular degeneration in China.