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

NCT05224102 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: ML43435
• Study Type: interventional
• Target: 218
• Locations: 4 countries
• Sites: 43

Brief 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 American/Alaska Native/Native Hawaiian or other Pacific Islander; in addition, a cohort of Asian Indian participants will be enrolled in India.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (3)

• 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

  From Baseline to Week 56

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

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

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

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

Secondary Outcomes (10)

• 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

  Baseline and Weeks 20 and 56

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

  Baseline and Weeks 20 and 56

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

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

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

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

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

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

Study Arms (2)

Main Phase: Faricimab

EXPERIMENTAL

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.

Drug: Faricimab

Long-Term Extension Phase: Faricimab

EXPERIMENTAL

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.

Drug: Faricimab

Interventions

Faricimab DRUG

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

Also known as: VABYSMO™, RO6867461, RG7716

Long-Term Extension Phase: Faricimab; Main Phase: Faricimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (43)

Barnet Dulaney Perkins Eye Center

Phoenix, Arizona, 85016, United States

Location

Win Retina

Arcadia, California, 91006, United States

Location

Retinal Diagnostic Center

Campbell, California, 95008, United States

Location

Retina Consultants of Orange County

Fullerton, California, 92835, United States

Location

Kaiser Permanente Southern California

Los Angeles, California, 90027, United States

Location

Retinal Consultants Medical Group

Sacramento, California, 95841-2013, United States

Location

Southwest Retina Consultants

Durango, Colorado, 81303, United States

Location

Emerson Clinical Research Institute LLC

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

Location

Blue Ocean Clinical Research

Clearwater, Florida, 33761-2046, United States

Location

Retina Macula Specialists of Miami - LeJeune Road Office

Miami, Florida, 33126-5690, United States

Location

Florida Retina Institute

Orlando, Florida, 32806-1101, United States

Location

Fort Lauderdale Eye Institute

Plantation, Florida, 33324, United States

Location

University Retina and Macula Associates, PC

Oak Forest, Illinois, 60452, United States

Location

Wilmer Eye Institute Johns Hopkins University

Baltimore, Maryland, 21287-0005, United States

Location

Md Medical Research

Oxon Hill, Maryland, 20745, United States

Location

Retina Associates of Michigan

Grand Blanc, Michigan, 48439-8301, United States

Location

Retina Consultants of Nevada

Henderson, Nevada, 89052, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

The Retina Center of New Jersey

Bloomfield, New Jersey, 07003-3000, United States

Location

NJ Retina - Teaneck

Teaneck, New Jersey, 07666-1704, United States

Location

Piedmont Retina Specialists

Winston-Salem, North Carolina, 27103-6970, United States

Location

Retina Associates of Cleveland, INC

Beachwood, Ohio, 44122-7340, United States

Location

Scheie Eye Institute

Philadelphia, Pennsylvania, 19104, United States

Location

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Black Hills Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Charles Retina Institute

Memphis, Tennessee, 38119, United States

Location

Austin Clinical Research LLC

Austin, Texas, 78750, United States

Location

Retina & Vitreous of Texas

Bellaire, Texas, 77401-3510, United States

Location

Brown Retina Institute

San Antonio, Texas, 78251-4551, United States

Location

Retina Center of Texas

Southlake, Texas, 76092, United States

Location

Strategic Clinical Research Group, LLC

Willow Park, Texas, 76087, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

Wagner Kapoor Institute

Norfolk, Virginia, 23502, United States

Location

MM Joshi Eye Institute

Hubli, Karnataka, 580021, India

Location

PBMA'S H. V. Desai Eye Hospital

Pune, Maharashtra, 411028, India

Location

M & J Western Regional Institute of Ophthalmology

Ahmedabad, Rajasthan, 380016, India

Location

Sankara Nethralaya

Chennai, Tamil Nadu, 600006, India

Location

Aravind Eye Hospital

Madurai, Tamil Nadu, 625020, India

Location

Regional Institute of Ophthalmology

Kolkata, West Bengal, 700073, India

Location

Post Graduate Institute of Medical Education and Research (PGIMER)

Chandigarh, 160012, India

Location

Nairobi Hospital

Nairobi, 00100, Kenya

Location

City Eye Hospital

Nairobi, 00202, Kenya

Location

Emanuelli Research and Development Center LLC

Arecibo, 00613, Puerto Rico

Location

MeSH Terms

Interventions

faricimab

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 4, 2022
• Study Start: February 28, 2022
• Primary Completion (Estimated): January 26, 2027
• Study Completion (Estimated): January 26, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KE (2); US (33); IN (7); PR (1)