Faricimab for Diabetic Macular Edema

(ELEVATUM Trial)

Recruiting at 52 trial locations

Overseen By Reference Study ID Number: ML43435 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Genentech, Inc.

Must be taking: Insulin, Anti-hyperglycemics

Must not be taking: Immunomodulators, Corticosteroids

Disqualifiers: Untreated diabetes, Active cancer, Stroke, others

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

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: 5

Duration: 52 weeks

218 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is designed to investigate treatment response in treatment-naïve underrepresented patients with diabetic macular edema (DME) who are treated with faricimab. The study population will consist of participants ≥18 years of age who self-identify as Black/African American, Hispanic/Latino American, or Native American/Alaska Native/Native Hawaiian or other Pacific Islander; in addition, a cohort of Asian Indian participants will be enrolled in India.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot participate if you are using certain systemic medications, like systemic corticosteroids or immunomodulatory treatments, within specific time frames before the trial starts. It's best to discuss your current medications with the trial team to see if they are allowed.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it does prohibit certain treatments like systemic corticosteroids, systemic immunomodulatory treatments, and medications toxic to the eye. It's best to discuss your current medications with the trial team to see if any are on the prohibited list.

What data supports the idea that Faricimab for Diabetic Macular Edema is an effective drug?

The available research shows that Faricimab is effective for treating Diabetic Macular Edema. It has been approved in the USA and Japan for this condition, indicating its effectiveness. The YOSEMITE and RHINE trials, which are phase III studies, have shown positive results in terms of efficacy and safety for patients with Diabetic Macular Edema. Additionally, Faricimab has been effective in patients who did not respond well to another treatment called Aflibercept, suggesting it can be a good alternative for those cases. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Faricimab for Diabetic Macular Edema?

Research shows that Faricimab, also known as Vabysmo, has been approved in the USA for treating diabetic macular edema (DME) and has demonstrated excellent visual acuity gains and strong durability in patients with DME and other eye conditions. Additionally, studies like the YOSEMITE and RHINE trials have shown its effectiveness and safety over a year in patients with DME. ^{1 2 3 4 5}

What safety data is available for Faricimab in treating diabetic macular edema?

Faricimab, also known as Vabysmo, has undergone several clinical trials to assess its safety in treating diabetic macular edema (DME). The Phase III YOSEMITE and RHINE trials, as well as the BOULEVARD trial, evaluated its safety profile. These studies demonstrated that Faricimab has a good safety profile, with results comparable to other treatments like ranibizumab and aflibercept. The trials showed that Faricimab is effective in improving visual acuity and reducing central retinal thickness, with a safety profile consistent with existing treatments for DME. ^{1 2 3 4 6}

Is Faricimab safe for humans?

Faricimab, also known as Vabysmo, has been studied in several clinical trials for conditions like diabetic macular edema and neovascular age-related macular degeneration. These studies, including the YOSEMITE, RHINE, TENAYA, and LUCERNE trials, have shown that Faricimab has a good safety profile, meaning it is generally safe for human use. ^{1 2 3 4 6}

Is the drug Faricimab a promising treatment for Diabetic Macular Edema?

Yes, Faricimab is a promising treatment for Diabetic Macular Edema. It has shown excellent results in improving vision and reducing the need for frequent injections. It targets two key factors involved in the disease, which helps in maintaining vision and reducing eye swelling. Clinical trials have demonstrated its effectiveness and potential for long-term use. ^{1 2 4 6 7}

What makes the drug Faricimab unique for treating diabetic macular edema?

Faricimab is unique because it is a bispecific antibody that targets both VEGF-A and Ang-2, which may improve treatment durability and outcomes compared to other treatments that only target VEGF-A. It also allows for longer intervals between injections, reducing the treatment burden for patients. ^{1 2 4 6 7}

Research Team

Clinical Trials

Principal Investigator

Genentech, Inc.

Eligibility Criteria

This trial is for treatment-naive adults with diabetic macular edema who identify as Black/African American, Hispanic/Latino American, Native American/Alaska Native/Native Hawaiian/Pacific Islander, or Asian Indian. Participants must have a specific level of vision impairment and controlled diabetes. Pregnant women and those with recent serious cardiovascular events or untreated diabetes are excluded.

Inclusion Criteria

Self-identify as Black/African American, Hispanic/Latino American, or Native American/Alaska Native/Native Hawaiian or other Pacific Islander; or self-identify as Asian Indian residents of the Indian subcontinent

Hemoglobin A1c (HbA1c) ≤10% (exceptions for up to 20% with HbA1c up to 12%)

I have diabetes and am currently using insulin or other diabetes medications.

Exclusion Criteria

I haven't taken any medication recently known to harm my organs.

I am currently on or have recently had treatment that weakens my immune system.

I have diabetes (type 1 or 2) and am not taking medication for it.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6-mg faricimab intravitreal injections once every 4 weeks up to Week 20, followed by once every 8 weeks up to Week 52

52 weeks

Injections every 4 weeks up to Week 20, then every 8 weeks up to Week 52

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person) at Week 56

Long-Term Extension

Eligible participants in the U.S. may continue receiving faricimab injections according to a personalized treatment interval

Variable, up to every 24 weeks

Treatment Details

Interventions

• Faricimab

Trial Overview The study tests Faricimab's effectiveness in underrepresented populations with diabetic macular edema. It focuses on patients without prior treatments for this condition to see how they respond to the medication.

Participant Groups

Group I: Main Phase: Faricimab Experimental Treatment 1 Intervention

Participants in the main study phase will receive 6-milligram (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) up to Week 20, followed by 6-mg IVT faricimab injections once every 8 weeks (Q8W) up to Week 52. Participants will return for the Week 56 safety follow-up visit after ≥28 days following their last study treatment.

Group II: Long-Term Extension Phase: Faricimab Experimental Treatment 1 Intervention

Eligible participants in the U.S. who opt to continue into the long-term extension (LTE) phase of this study will receive 6-mg faricimab IVT injections according to the personalized treatment interval (PTI) dosing algorithm. The minimum and maximum PTIs in the LTE are Q4W and once every 24 weeks (Q24W), respectively.

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?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Findings from Research

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]

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]

Faricimab demonstrated significant improvements in best-corrected visual acuity (BCVA) for patients with diabetic macular edema, with similar efficacy observed in both Asian (average gain of +10.4 letters) and non-Asian (average gain of +11.1 letters) subgroups after one year.

The treatment was well tolerated with no new safety concerns, and a high percentage of patients in both groups achieved extended dosing intervals, indicating the durability of the treatment effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, Durability, and Safety of Faricimab in Patients From Asian Countries With Diabetic Macular Edema: 1-Year Subgroup Analysis of the Phase III YOSEMITE and RHINE Trials. Ishida, S., Chen, SJ., Murata, T., et al.[2023]

Faricimab demonstrated significant improvements in best-corrected visual acuity (BCVA) in Japanese patients with diabetic macular edema (DME), with mean changes of +11.1 letters for Q8W dosing and +8.1 letters for personalized treatment intervals, comparable to the global results.

The treatment was well tolerated with no new safety concerns, and a majority of patients in the personalized treatment interval group were able to extend dosing to every 12 or 16 weeks, indicating durable efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, durability, and safety of faricimab with extended dosing up to every 16 weeks in Japanese patients with diabetic macular edema: 1-year results from the Japan subgroup of the phase 3 YOSEMITE trial. Shimura, M., Kitano, S., Ogata, N., et al.[2023]

In a study of 51 patients with treatment-resistant diabetic macular edema (DME), switching from intravitreal aflibercept (IVA) to intravitreal faricimab (IVF) resulted in significant improvements, with 39.2% achieving a treatment interval of 8 weeks or more and a fluid-free macula after 12 months.

The central macular thickness (CMT) decreased significantly from 400.2 microns to 340.6 microns, and 21.6% of patients experienced a visual acuity improvement of 3 lines or more, indicating that IVF may be an effective alternative for patients not responding to IVA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One Year Results of Faricimab for Aflibercept-Resistant Diabetic Macular Edema. Rush, RB.[2023]

Faricimab, a dual-target antibody for VEGF-A and Ang-2, has shown comparable efficacy to monthly ranibizumab in treating neovascular age-related macular degeneration, allowing for longer intervals between injections and fewer treatments overall.

In the BOULEVARD trial, faricimab significantly improved diabetic retinopathy severity in 38.6% of patients treated with the highest dose, outperforming ranibizumab, indicating its potential for effective long-term management of diabetic macular edema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Faricimab: from research to clinical practice]. Yusef, YN., Budzinskaya, MV., Plyukhova, AA.[2023]

Faricimab is a new bispecific antibody that targets both angiopoietin-2 and VEGF, which may enhance treatment durability and improve outcomes for patients with diabetic macular edema (DME).

The YOSEMITE and RHINE trials, involving 940 and 951 participants respectively, are the first to use a personalized treatment interval (PTI) approach, allowing for flexible dosing up to every 16 weeks, aimed at maximizing therapeutic results while reducing treatment burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

YOSEMITE and RHINE: Phase 3 Randomized Clinical Trials of Faricimab for Diabetic Macular Edema: Study Design and Rationale. Eter, N., Singh, RP., Abreu, F., et al.[2022]

References

1. 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]

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

Faricimab: First Approval. [2022]

3. China pubmed.ncbi.nlm.nih.gov

Efficacy, Durability, and Safety of Faricimab in Patients From Asian Countries With Diabetic Macular Edema: 1-Year Subgroup Analysis of the Phase III YOSEMITE and RHINE Trials. [2023]

4. Japan pubmed.ncbi.nlm.nih.gov

Efficacy, durability, and safety of faricimab with extended dosing up to every 16 weeks in Japanese patients with diabetic macular edema: 1-year results from the Japan subgroup of the phase 3 YOSEMITE trial. [2023]

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

One Year Results of Faricimab for Aflibercept-Resistant Diabetic Macular Edema. [2023]

6. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Faricimab: from research to clinical practice]. [2023]

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

YOSEMITE and RHINE: Phase 3 Randomized Clinical Trials of Faricimab for Diabetic Macular Edema: Study Design and Rationale. [2022]