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Monoclonal Antibodies

Faricimab for Diabetic Macular Edema (ELEVATUM Trial)

Phase 4

Recruiting

Research Sponsored by Genentech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of diabetes mellitus (type 1 or type 2) and current regular use of insulin or other injectable drugs or oral anti-hyperglycemic agents

Be older than 18 years old

Must not have

Specific ocular conditions or treatments in the study eye or non-study eye as detailed in the criteria

Use of specific medications known to be toxic to certain organs within specified timeframes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial is designed to see if faricimab is an effective treatment for diabetic macular edema in underrepresented patients who have not yet received treatment. The study population will consist of participants who self-identify as Black/African American, Hispanic/Latino American, or Native American/Alaska Native/Native Hawaiian or other Pacific Islander.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of similar eye injections like Faricimab may include redness, discomfort at the injection site, increased intraocular pressure, and potential risk of eye infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My eyes have specific conditions or have received certain treatments as listed.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2023 Phase 3 trial • 1479 Patients • NCT04432831

11%

Cataract

10%

COVID-19

Nasopharyngitis

Diabetic retinal oedema

Hypertension

Intraocular pressure increased

Urinary tract infection

Diabetic retinopathy

Posterior capsule opacification

Myocardial infarction

Cerebrovascular accident

Vitreous floaters

Vitreous haemorrhage

Anaemia

Acute myocardial infarction

Cardiac failure

COVID-19 pneumonia

Cellulitis

Gangrene

Pneumonia

Sepsis

Vitreous detachment

Conjunctival haemorrhage

Atrial fibrillation

Acute kidney injury

100%

80%

60%

40%

20%

Study treatment Arm

Faricimab PTI (Prior Aflibercept Q8W)

Faricimab PTI (Prior Faricimab Q8W)

Faricimab PTI (Prior Faricimab PTI)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Main Phase: FaricimabExperimental Treatment1 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: FaricimabExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Faricimab

2023

Completed Phase 3

~7760

0 / 4Eligibility criteria met