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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.
Select...
I haven't taken any medication recently known to harm my organs.
Select...
I have diabetes (type 1 or 2) and am not taking medication for it.

Timeline

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
5%
Nasopharyngitis
5%
Diabetic retinal oedema
5%
Hypertension
3%
Urinary tract infection
3%
Diabetic retinopathy
3%
Intraocular pressure increased
3%
Posterior capsule opacification
2%
Myocardial infarction
2%
Cerebrovascular accident
2%
Vitreous floaters
1%
Anaemia
1%
Acute myocardial infarction
1%
Cardiac failure
1%
COVID-19 pneumonia
1%
Cellulitis
1%
Gangrene
1%
Pneumonia
1%
Sepsis
1%
Vitreous detachment
1%
Conjunctival haemorrhage
1%
Atrial fibrillation
1%
Acute kidney injury
1%
Vitreous haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Faricimab PTI (Prior Aflibercept Q8W)
Faricimab PTI (Prior Faricimab PTI)
Faricimab PTI (Prior Faricimab Q8W)

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

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,563 Previous Clinical Trials
569,871 Total Patients Enrolled
Clinical TrialsStudy DirectorGenentech, Inc.
2,227 Previous Clinical Trials
896,204 Total Patients Enrolled

Media Library

Faricimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05224102 — Phase 4
Diabetic Macular Edema Research Study Groups: Main Phase: Faricimab, Long-Term Extension Phase: Faricimab
Diabetic Macular Edema Clinical Trial 2023: Faricimab Highlights & Side Effects. Trial Name: NCT05224102 — Phase 4
Faricimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05224102 — Phase 4
~92 spots leftby Nov 2026
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