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Faricimab for Diabetic Macular Edema (ELEVATUM Trial)
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.
ELEVATUM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowELEVATUM Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 3 trial • 940 Patients • NCT03622580ELEVATUM Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Main Phase: Faricimab
- Group 2: Long-Term Extension Phase: Faricimab
- 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.
- 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
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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