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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, 52, and 56
Awards & highlights
ELEVATUM Trial 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.Check my eligibility
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.See study design
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.
ELEVATUM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have diabetes and am currently using insulin or other diabetes medications.
ELEVATUM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, 52, and 56
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, 52, and 56
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Long-Term Extension Phase: Incidence and Severity of Non-Ocular Adverse Events
Long-Term Extension Phase: Incidence and Severity of Ocular Adverse Events
Main Phase: Change in Best Corrected Visual Acuity (BCVA) from Baseline at Week 56, as Measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at a Starting Distance of 4 Meters
Secondary outcome measures
Main Phase: Change from Baseline in Central Subfield Thickness Over Time
Main Phase: Incidence and Severity of Non-Ocular Adverse Events
Main Phase: Incidence and Severity of Ocular Adverse Events
+7 moreSide effects data
From 2021 Phase 3 trial • 940 Patients • NCT0362258018%
Cataract
12%
Hypertension
11%
Diabetic retinal oedema
10%
Nasopharyngitis
8%
Conjunctival haemorrhage
6%
Urinary tract infection
4%
Vitreous detachment
4%
Intraocular pressure increased
3%
Vitreous floaters
3%
Fall
2%
Pneumonia
2%
Myocardial infarction
2%
Cardiac failure congestive
2%
Osteomyelitis
2%
Sepsis
1%
Chest pain
1%
Coronary artery disease
1%
Cellulitis
1%
Chronic kidney disease
1%
COVID-19
1%
Cerebrovascular accident
1%
Acute kidney injury
1%
Acute respiratory failure
1%
Syncope
1%
Osteoarthritis
1%
Adenocarcinoma of colon
1%
Cellulitis gangrenous
1%
End stage renal disease
1%
Retinal artery occlusion
1%
COVID-19 pneumonia
1%
Gangrene
1%
Anaemia
1%
Acute left ventricular failure
1%
Acute myocardial infarction
1%
Angina pectoris
1%
Diabetic retinopathy
1%
Diabetic foot infection
1%
Ischaemic stroke
1%
Renal failure
1%
Diabetic foot
100%
80%
60%
40%
20%
0%
Study treatment Arm
C: Aflibercept 2 mg Q8W
A: Faricimab 6 mg Q8W
B: Faricimab 6 mg PTI
ELEVATUM 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
~6720
Find a Location
Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,539 Previous Clinical Trials
567,471 Total Patients Enrolled
Clinical TrialsStudy DirectorGenentech, Inc.
2,199 Previous Clinical Trials
888,284 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My eyes have specific conditions or have received certain treatments as listed.I have diabetes and am currently using insulin or other diabetes medications.I do not have uncontrolled blood pressure, kidney failure, a weak immune system, or recent substance abuse.I have had active cancer in the last year, except for certain types.I have not had a stroke or heart attack in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Main Phase: Faricimab
- Group 2: Long-Term Extension Phase: Faricimab
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many venues are currently hosting this trial?
"Numerous potential sites are available for this trial, such as Kaiser Permanente Southern California in Riverside, NJ Retina-Toms River in Toms River and Atrium Health Wake Forest University School of Medicine - PPDS in Winston-Salem. There are 39 locations total."
Answered by AI
How many people have taken part in this trial thus far?
"Affirmative. According to data posted on clinicaltrials.gov, this medical research has been accepting applications since February 28th 2022 and was last updated November 10th 2022. 39 different healthcare facilities are working together to recruit a total of 120 patients for the trial."
Answered by AI
How hazardous is Faricimab when administered to patients?
"Due to its Phase 4 trial status, Faricimab has been officially approved and thus receives a score of 3 on the safety scale."
Answered by AI
Are researchers still signing up participants for this research study?
"Affirmative. Clinicaltrials.gov displays that this clinical trial, which debuted on February 28th 2022, is actively recruiting patients. As such, 120 study participants need to be enrolled from 39 different medical facilities."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Retina & Vitreous of Texas
Brown Retina Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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