Faricimab Schedules for Age-Related Macular Degeneration

(AO Trial)

Recruiting in Palo Alto (17 mi)

+47 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Jaeb Center for Health Research

Must not be taking: Anti-VEGF, Corticosteroids

Disqualifiers: Dense cataract, Pathologic myopia, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Home optical coherence tomography- guided treatment versus treat and extend for the management of neovascular age-related macular degeneration.

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.

What data supports the effectiveness of the drug Faricimab for age-related macular degeneration?

Research shows that Faricimab is effective in treating age-related macular degeneration, especially in patients who did not respond well to other treatments. It helps reduce fluid in the eye and preserve vision, even in difficult cases.

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Is Faricimab safe for humans?

Faricimab, also known as Vabysmo, has been studied for safety in treating eye conditions like age-related macular degeneration and diabetic macular edema. Clinical trials have evaluated its safety, and it has been approved for use in the USA and Japan, indicating it is generally considered safe for these conditions.

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How is the drug Faricimab unique for treating age-related macular degeneration?

Faricimab is unique because it is a bispecific antibody that targets both VEGF-A and Ang-2, which helps improve vision and offers longer-lasting effects compared to traditional treatments that only target VEGF-A. It is administered through an injection into the eye, providing a novel approach for patients who have not responded well to other treatments.

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Eligibility Criteria

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.

Trial Timeline

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)

Participant Groups

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.

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The Retina Institute St. Louis, MO

Texas Retina Associates Lubbock, TX

National Ophthalmic Research Institute Fort Myers, FL

Thomas Eye Group Sandy Springs, GA

More Trial Locations

Who Is Running the Clinical Trial?

Jaeb Center for Health Research Lead Sponsor

National Eye Institute (NEI) Collaborator

Juvenile Diabetes Research Foundation Collaborator

National Institutes of Health (NIH) Collaborator

References

1. Germany 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. [2023] To evaluate the efficacy, safety and durability of intravitreal faricimab in patients with neovascular age-related macular degeneration (nAMD) with unsatisfactory response to traditional anti-vascular endothelial growth factor (anti-VEGF) agents.

2. England 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. [2023] Investigate real-world patients receiving faricimab for the treatment of neovascular age-related macular degeneration (nAMD).

3. United States pubmed.ncbi.nlm.nih.gov

Faricimab Effectively Resolves Intraretinal Fluid and Preserves Vision in Refractory, Recalcitrant, and Nonresponsive Neovascular Age-Related Macular Degeneration. [2023] To evaluate the functional and anatomic outcomes of faricimab treatment in patients with neovascular age-related macular degeneration (nAMD) who are unresponsive to other anti-vascular endothelial growth factor (VEGF) therapies.

4. Netherlands pubmed.ncbi.nlm.nih.gov

Machine Learning to Predict Faricimab Treatment Outcome in Neovascular Age-Related Macular Degeneration. [2023] To develop machine learning (ML) models to predict, at baseline, treatment outcomes at month 9 in patients with neovascular age-related macular degeneration (nAMD) receiving faricimab.

5. Germany pubmed.ncbi.nlm.nih.gov

Short-term outcomes of intravitreal faricimab for treatment-naïve neovascular age-related macular degeneration. [2023] To investigate the efficacy and safety of loading phase treatment with 3 monthly intravitreal injections of faricimab for neovascular age-related macular degeneration (nAMD).

6. New Zealand pubmed.ncbi.nlm.nih.gov

Faricimab: First Approval. [2022] Faricimab (faricimab-svoa; Vabysmo™) is a bispecific antibody that binds to and inhibits both vascular endothelial growth factor (VEGF)-A and angiopoietin-2 (Ang-2). Administered by intravitreal injection, faricimab is being developed by Roche/Genentech for use in the treatment of retinal vascular diseases. In January 2022 faricimab received its first approvals, in the USA, for use in the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD) or diabetic macular edema (DME). Faricimab has also recently been approved in Japan, and is currently under regulatory review in the EU, for use in nAMD and DME. Phase III clinical development of faricimab for use in the treatment of nAMD, DME, and macular edema due to retinal vein occlusion is continuing in multiple other countries worldwide. This article summarizes the milestones in the development of faricimab leading to these first approvals for nAMD and DME in the USA.

7. Netherlands pubmed.ncbi.nlm.nih.gov

BALATON and COMINO: Phase III Randomized Clinical Trials of Faricimab for Retinal Vein Occlusion: Study Design and Rationale. [2023] Dual inhibition of angiopoietin-2 and VEGF-A with faricimab (Vabysmo) offers excellent visual acuity gains with strong durability in patients with diabetic macular edema (ME) and neovascular age-related macular degeneration. The phase III BALATON/COMINO (NCT04740905/NCT04740931) trials will investigate the efficacy, safety, and durability of faricimab in patients with ME due to retinal vein occlusion (RVO).

8. Germany 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. [2023] To evaluate 1-year efficacy, durability, and safety of faricimab among patients from Asian countries in the TENAYA/LUCERNE trials of neovascular age-related macular degeneration (nAMD).

9. England pubmed.ncbi.nlm.nih.gov

Eligibility for faricimab in a real-world neovascular age-related macular degeneration population: a cross-sectional study. [2022] To investigate the eligibility of a real-world neovascular age-related macular degeneration (nAMD) population for the TENAYA and LUCERNE trials (testing faricimab), and to compare the eligible real-world patients to trial participants.