Faricimab for Diabetic Macular Edema

(ELEVATUM Trial)

Not currently recruiting at 54 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of faricimab (an eye injection) for individuals with diabetic macular edema (DME), a condition where fluid accumulates in the eye due to diabetes, leading to vision problems. The trial focuses on patients who have not previously received eye injections for DME and belong to specific underrepresented groups. Participants should have diabetes and be taking insulin or another diabetes medication. The trial requires regular eye injections and seeks individuals who can commit to a long-term study. As a Phase 4 trial, this research helps determine how the already FDA-approved and effective treatment benefits a broader range of patients.

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 is the safety track record for faricimab?

Research has shown that faricimab is generally well-tolerated by people with diabetic macular edema (DME). Studies have found that common side effects include mild eye discomfort and redness, which are not serious. The FDA has approved the treatment for use in DME, indicating a strong safety record.

In earlier studies, a few patients experienced more serious side effects, such as increased pressure inside the eye, but these were rare. Most people did not encounter major issues. This suggests that faricimab is safe for most patients, although a small risk of side effects remains. Always consult a healthcare provider about potential risks before joining a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Faricimab is unique because it targets both angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), offering a dual-action approach for treating diabetic macular edema. Current treatments, like aflibercept and ranibizumab, primarily focus on inhibiting VEGF-A alone. This dual-targeting mechanism may provide more comprehensive control of the disease and potentially extend the duration between injections, which could be a significant advantage for patients. Researchers are excited because this could mean fewer injections and improved outcomes for patients managing this chronic condition.

What is the effectiveness track record for faricimab in treating diabetic macular edema?

Research shows that faricimab effectively treats diabetic macular edema (DME). Studies have demonstrated that it can significantly improve vision and reduce or eliminate swelling at the back of the eye. In this trial, participants in the main phase will receive faricimab every four weeks up to Week 20, then every eight weeks up to Week 52. Another study found that faricimab maintained vision improvements even when the interval between doses extended to 16 weeks. These results support faricimab as a promising treatment for DME. ^{1 2 3 6 7}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Genentech, Inc.

Are You a Good Fit for This Trial?

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

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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 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]

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, 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]

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]

Citations

1. 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03622593

NCT03622593 | A Study to Evaluate the Efficacy and ... A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (RHINE). ClinicalTrials.gov ID NCT03622593.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03622580

NCT03622580 | A Study to Evaluate the Efficacy and ... This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following ...

4. roche.com roche.com/media/releases/med-cor-2020-12-21

Roche's faricimab meets primary endpoint and shows ... Faricimab given every eight weeks and at personalised dosing intervals of up to 16 weeks demonstrated non-inferior visual acuity gains ...

5. gene.com gene.com/media/press-releases/14891/2020-12-20/genentechs-faricimab-meets-primary-endpo

Genentech: Press Releases | Sunday, Dec 20, 2020 Genentech's Faricimab meets primary endpoint and shows strong durability across two global Phase III studies for diabetic macular edema, a leading cause of ...

6. assets.roche.com assets.roche.com/f/203780/x/8de4ac9bce/vabysmo-product-information-ro-6867461-november-2023.pdf

VABYSMO® INN: Faricimab Diabetic macular edema (DME). The recommended dose for VABYSMO is 6 ... The safety data described below include all adverse reactions from the ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2022/761235Orig1s000MedR.pdf

761235Orig1s000 CLINICAL REVIEW(S) - accessdata.fda.gov Safety of Faricimab (RO6867461) in Patients with Diabetic Macular Edema. 6.3.1. Study Design. Primary Objective: Evaluate the efficacy of ...