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

Running, not enrolling · Phase 4

Conditions studied: Diabetic Macular Edema

In brief

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.

Key facts

Study ID

NCT05224102

Run by

Genentech, Inc.

People needed

218

Starts

2022-02-28

Expected to finish

2027-01-26

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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

You may not qualify if…

• 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
• 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

Where it is running

• Barnet Dulaney Perkins Eye Center — Phoenix, Arizona, United States
• Win Retina — Arcadia, California, United States
• Retinal Diagnostic Center — Campbell, California, United States
• Retina Consultants of Orange County — Fullerton, California, United States
• Kaiser Permanente Southern California — Los Angeles, California, United States
• Retinal Consultants Medical Group — Sacramento, California, United States
• Southwest Retina Consultants — Durango, Colorado, United States
• Emerson Clinical Research Institute LLC — Washington D.C., District of Columbia, United States
• Blue Ocean Clinical Research — Clearwater, Florida, United States
• Retina Macula Specialists of Miami - LeJeune Road Office — Miami, Florida, United States
• Florida Retina Institute — Orlando, Florida, United States
• Fort Lauderdale Eye Institute — Plantation, Florida, United States
• University Retina and Macula Associates, PC — Oak Forest, Illinois, United States
• Wilmer Eye Institute Johns Hopkins University — Baltimore, Maryland, United States
• Md Medical Research — Oxon Hill, Maryland, United States
• Retina Associates of Michigan — Grand Blanc, Michigan, United States
• Retina Consultants of Nevada — Henderson, Nevada, United States
• Sierra Eye Associates — Reno, Nevada, United States
• The Retina Center of New Jersey — Bloomfield, New Jersey, United States
• NJ Retina - Teaneck — Teaneck, New Jersey, United States
• Piedmont Retina Specialists — Winston-Salem, North Carolina, United States
• Retina Associates of Cleveland, INC — Beachwood, Ohio, United States
• Scheie Eye Institute — Philadelphia, Pennsylvania, United States
• Wills Eye Hospital — Philadelphia, Pennsylvania, United States
• Black Hills Eye Institute — Rapid City, South Dakota, United States

Full record on ClinicalTrials.gov

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