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Diabetic Macular EdemaPhase 4ELEVATUMNCT05224102

A Study to Investigate Faricimab Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema

A Phase 4 study testing Faricimab in people with Diabetic Macular Edema, run by Genentech, Inc. at 43 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is designed to investigate treatment response in treatment-naïve underrepresented patients with diabetic macular edema (DME) who are treated with faricimab. The study population will consist of participants ≥18 years of age who self-identify as Black/African American, Hispanic/Latino American, or Native… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Faricimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
218 participants
Where
43 sitesin 4 countries
Study dates
28 Feb 2022to 26 Jan 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Main Phase General 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
  • Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association, and current regular use of insulin or other injectable drugs (e.g., dulaglutide and liraglutide) and/or oral anti-hyperglycemic agents for the treatment of diabetes
  • Hemoglobin A1c (HbA1c) ≤10% (Note: up to 20% of participants enrolled may have HbA1c up to 12%)
  • For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraception methods as defined in the protocol
  • Main Phase Ocular Inclusion Criteria for Study Eye:
Show all 15Show fewer
  • Intravitreal (IVT) treatment-naïve in the study eye (i.e., have not received previous treatment with any anti-VEGF IVT or any corticosteroids periocular or IVT in the study eye)
  • Diabetic macular edema, defined as macular thickening by SD-OCT involving the center of the macula
  • BCVA letter score of 73 to 20 letters (both inclusive) using the ETDRS protocol at the initial testing distance of 4 meters at the baseline visit (Day 1)
  • Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis
  • Long-Term Extension (LTE) Inclusion Criteria:
  • Enrollment in and completion of the main study, without discontinuation from study or study drug treatment
  • Signed LTE-phase Informed Consent Form
  • Ability to comply with the study protocol, in the investigator's judgment
  • For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraception methods as defined in the protocol

Who cannot join

  • Main Phase General Exclusion Criteria:
  • Diabetes mellitus (type 1 or type 2) that is currently medically untreated
  • Previously untreated diabetes mellitus (type 1 or type 2) who started on oral or injectable anti-diabetic medication within 3 months prior to Day 1
  • Any known hypersensitivity to any of the components in the faricimab injection
  • Any known hypersensitivity to any contrast media (e.g., fluorescein), dilating eye drops, disinfectants (e.g., iodine), or any of the anesthetics and antimicrobial preparations used by the patient during the study
  • History of other diseases, other non-diabetic metabolic dysfunction, physical examination finding, or historical or current clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of the faricimab or that might affect interpretation of the results of the study or renders the patient at high-risk for treatment complications, in the opinion of the investigator
Show all 50Show fewer
  • Active cancer within the past 12 months prior to Day 1 except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of ≤6 and a stable prostate-specific antigen for >12 months
  • Stroke (cerebral vascular accident) or myocardial infarction within 12 months prior to Day 1
  • Any febrile illness within 1 week prior to Day 1
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of faricimab
  • Uncontrolled blood pressure, defined as systolic >180 mmHg and/or diastolic >100 mmHg (while patient is at rest in a sitting position); if a patient's initial reading exceeds these values, a second reading may be taken ≥30 minutes later on the same day
  • Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis within 6 months prior to Day 1 or anticipated to require hemodialysis or peritoneal dialysis at any time during the study
  • Any condition resulting in a compromised immune system that is likely to impact the aqueous humor inflammatory biomarkers
  • Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins or minerals) within 3 months (or 5 half-lives, whichever is longer) prior to Day 1, or during the course of this study
  • Substance abuse occurring within 12 months prior to screening, in the investigator's judgment
  • Use of systemic immunomodulatory treatments (e.g., IL-6 inhibitors) within 6 months or 5 half-lives (whichever is longer) prior to Day 1
  • Use of any systemic corticosteroids within 1 month prior to Day 1
  • Systemic treatment for suspected or active systemic infection
  • Any prior or concomitant systemic anti-VEGF treatment within 6 months or 5 half-lives (whichever is longer) prior to Day 1
  • Use of systemic medications known to be toxic to the lens, retina, or optic nerve (e.g., deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, or ethambutol) during the 6-months (or 5 half-lives, whichever is longer) prior to Day 1
  • Receiving any treatment that leads to immunosuppression within 6 months (or 5 half-lives, whichever is longer) prior to Day 1
  • Requiring continuous use of any medications or treatments listed as prohibited therapy
  • Main Phase Ocular Exclusion Criteria for Study Eye:
  • High-risk proliferative diabetic retinopathy (PDR) in the study eye, using any of the following established criteria for high-risk PDR: Any vitreous or pre-retinal hemorrhage; Neovascularization elsewhere ≥1/2 disc area within an area equivalent to the mydriatic ETDRS 7 or 4 fields on clinical examination or on CFPs; Neovascularization at disc ≥1/3 disc area on clinical examination
  • Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular architecture in the study eye, as evaluated by the central reading center
  • Any history of or ongoing rubeosis iridis
  • Any panretinal photocoagulation or macular laser (focal, grid or micropulse) photocoagulation treatment received in the study eye prior Day 1
  • Any history of treatment with anti-VEGF or any periocular or IVT corticosteroids in the study eye prior to Day 1
  • Any treatment for dry eye disease in the last month prior to Day 1 (e.g., cyclosporine eye drops, lifitegrast eye drops). Lubricating eye drops and ointments are permitted.
  • Any treatment with anti-inflammatory eye drops (e.g., doxycycline) within 1 month prior to Day 1
  • Any intraocular surgery (e.g., cataract surgery) within 3 months prior to Day 1 or any planned surgery during the study
  • Any glaucoma surgery prior to the screening visit
  • History of vitreoretinal surgery/pars plana vitrectomy, corneal transplant, or radiotherapy
  • Uncontrolled glaucoma
  • Any active or suspected ocular or periocular infections on Day 1
  • Any presence of active intraocular inflammation on Day 1 (i.e., Standardization of Uveitis Nomenclature [SUN] criteria >0 or National Eye Institute [NEI] vitreous haze grading >0) or any history of intraocular inflammation
  • Any history of idiopathic, infectious, or noninfectious uveitis
  • Any current ocular condition or other causes of visual impairment for which, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema
  • Main Phase Ocular Exclusion Criteria for Non-Study Eye:
  • Any history of idiopathic or immune-mediated uveitis
  • Active ocular inflammation or suspected or active ocular or periocular infection on Day 1
  • Currently receiving treatment with brolucizumab or bevacizumab in the non-study eye and is unwilling to switch to a protocol-allowed, non-study eye anti-VEGF treatment during the study
  • Any previous treatment with Iluvien® or Retisert® (fluocinolone acetonide IVT implant) in the non-study eye
  • Non-functioning non-study eye, defined as either: BCVA of hand motion or worse; No physical presence of non-study eye (i.e., monocular); or, Legally blind in the patient's relevant jurisdiction
  • Long-Term Extension (LTE) Exclusion Criteria:
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final IVT injection of faricimab
  • Presence of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of faricimab, that might affect interpretation of the results of the LTE, or that renders the patient at high risk for treatment complications
  • Presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of faricimab and that might affect interpretation of the results of the LTE, or that renders the patient at high risk of treatment complications
  • History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injections, study treatment procedure, dilating drops, or any of the anesthetic and antimicrobial preparations used by a patient during the LTE phase
  • Requirement for continuous use of any medications or treatments indicated as prohibited therapy (as defined in the protocol)

Trial locations and contacts

43 sites in 4 countries.

43 sites in 4 countries

United States33 sites

  • Win Retina

    Arcadia, California, 91006

  • Austin Clinical Research LLC

    Austin, Texas, 78750

  • Wilmer Eye Institute Johns Hopkins University

    Baltimore, Maryland, 21287-0005

  • Retina Associates of Cleveland, INC

    Beachwood, Ohio, 44122-7340

  • Retina & Vitreous of Texas

    Bellaire, Texas, 77401-3510

  • The Retina Center of New Jersey

    Bloomfield, New Jersey, 07003-3000

  • Retinal Diagnostic Center

    Campbell, California, 95008

  • Blue Ocean Clinical Research

    Clearwater, Florida, 33761-2046

  • Southwest Retina Consultants

    Durango, Colorado, 81303

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • Retina Associates of Michigan

    Grand Blanc, Michigan, 48439-8301

  • Retina Consultants of Nevada

    Henderson, Nevada, 89052

  • Kaiser Permanente Southern California

    Los Angeles, California, 90027

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502

  • Charles Retina Institute

    Memphis, Tennessee, 38119

  • Retina Macula Specialists of Miami - LeJeune Road Office

    Miami, Florida, 33126-5690

  • Wagner Kapoor Institute

    Norfolk, Virginia, 23502

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois, 60452

  • Florida Retina Institute

    Orlando, Florida, 32806-1101

  • Md Medical Research

    Oxon Hill, Maryland, 20745

  • Scheie Eye Institute

    Philadelphia, Pennsylvania, 19104

  • Wills Eye Hospital

    Philadelphia, Pennsylvania, 19107

  • Barnet Dulaney Perkins Eye Center

    Phoenix, Arizona, 85016

  • Fort Lauderdale Eye Institute

    Plantation, Florida, 33324

  • Black Hills Eye Institute

    Rapid City, South Dakota, 57701

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Retinal Consultants Medical Group

    Sacramento, California, 95841-2013

  • Retina Consultants of Texas Westover Hills Retina Center

    San Antonio, Texas, 78251

  • Retina Center of Texas

    Southlake, Texas, 76092

  • NJ Retina - Teaneck

    Teaneck, New Jersey, 07666-1704

  • Emerson Clinical Research Institute LLC

    Washington D.C., District of Columbia, 20011-3010

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087

  • Piedmont Retina Specialists

    Winston-Salem, North Carolina, 27103-6970

Other trials in United States

India7 sites

  • M & J Western Regional Institute of Ophthalmology

    Ahmedabad, Rajasthan, 380016

  • Post Graduate Institute of Medical Education and Research (PGIMER)

    Chandigarh, 160012

  • Sankara Nethralaya

    Chennai, Tamil Nadu, 600006

  • MM Joshi Eye Institute

    Hubli, Karnataka, 580021

  • Regional Institute of Ophthalmology

    Kolkata, West Bengal, 700073

  • Aravind Eye Hospital

    Madurai, Tamil Nadu, 625020

  • PBMA'S H. V. Desai Eye Hospital

    Pune, Maharashtra, 411028

Other trials in India

Kenya2 sites

  • Nairobi Hospital

    Nairobi, 00100

  • City Eye Hospital

    Nairobi, 00202

Other trials in Kenya

Puerto Rico1 site

  • Emanuelli Research and Development Center LLC

    Arecibo, 00613

Other trials in Puerto Rico

About this study

Official title: A Phase IV, Multicenter, Open-Label, Single-Arm Study to Investigate Faricimab (RO6867461) Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema

This study is designed to investigate treatment response in treatment-naïve underrepresented patients with diabetic macular edema (DME) who are treated with faricimab. The study population will consist of participants ≥18 years of age who self-identify as Black/African American, Hispanic/Latino American, or Native American/Alaska Native/Native Hawaiian or other Pacific Islander; in addition, a cohort of Asian Indian participants will be enrolled in India.

Being tested
Faricimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FaricimabDrug

    Also called VABYSMO™, RO6867461, RG7716

    Participants will receive 6-milligram (mg) faricimab intravitreal (IVT) injections, as described in the study arm descriptions for each study phase.

Study groups in NCT05224102
Study groupRoleWhat they receive
Main Phase: FaricimabExperimentalParticipants 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.
Receives: Drug: Faricimab
Long-Term Extension Phase: FaricimabExperimentalEligible 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.
Receives: Drug: Faricimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From Baseline to Week 56

  2. Long-Term Extension Phase: Incidence and Severity of Ocular Adverse Events

    Measured: From Day 1 until end of long-term extension (up to 100 weeks)

  3. Long-Term Extension Phase: Incidence and Severity of Non-Ocular Adverse Events

    Measured: From Day 1 until end of long-term extension (up to 100 weeks)

Secondary outcomes (10)

  1. Main Phase: Percentage of Participants with a Greater Than or Equal to (≥)2-Step ETDRS Diabetic Retinopathy Severity Scale (DRSS) Improvement from Baseline Over Time

    Measured: Baseline and Weeks 20 and 56

  2. Main Phase: Percentage of Participants with a ≥3-Step ETDRS Diabetic Retinopathy Severity Scale (DRSS) Improvement from Baseline Over Time

    Measured: Baseline and Weeks 20 and 56

  3. Main Phase: Percentage of Participants with Absence of Intraretinal Fluid Over Time

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, 52, and 56

  4. Main Phase: Percentage of Participants with Absence of Subretinal Fluid Over Time

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, 52, and 56

  5. Main Phase: Change from Baseline in Central Subfield Thickness Over Time

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, 52, and 56

  6. Main Phase: Percentage of Participants Gaining ≥15 or ≥10 Letters in BCVA from Baseline at Week 56

    Measured: Baseline and Week 56

  7. Main Phase: Percentage of Participants Avoiding a Loss of ≥15 or ≥10 Letters in BCVA from Baseline at Week 56

    Measured: Baseline and Week 56

  8. Main Phase: Incidence and Severity of Ocular Adverse Events

    Measured: From Baseline up to Week 56

  9. Main Phase: Incidence and Severity of Non-Ocular Adverse Events

    Measured: From Baseline up to Week 56

  10. Main Phase: Number of Participants Testing Positive for Anti-Drug Antibodies (ADAs) Against Faricimab at Baseline and Anytime During the Study

    Measured: From Baseline up to Week 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2022
  2. Study start28 Feb 2022
  3. Primary completion26 Jan 2027 (estimated)
  4. Study completion26 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
This is a multicenter, open-label, single-arm study with two phases: the main study phase for all eligible patients (up to 56 weeks), followed by an optional long-term extension phase for eligible patients only in the U.S. (up to 100 weeks).
Masking
None (open label)
Enrolment
218 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05224102
Sponsor's protocol ID
ML43435
Acronym
ELEVATUM
Status last verified
Aug 2026
First submitted
25 Jan 2022
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Faricimab in people with Diabetic Macular Edema, run by Genentech, Inc. at 43 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 50 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, India, Kenya, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: From Baseline to Week 56). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05224102.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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