A Study to Investigate Faricimab Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema
NCT ID: NCT05224102
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
218 participants
INTERVENTIONAL
2022-02-28
2027-01-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Main Phase: Faricimab
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.
Faricimab
Participants will receive 6-milligram (mg) faricimab intravitreal (IVT) injections, as described in the study arm descriptions for each study phase.
Long-Term Extension Phase: Faricimab
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.
Faricimab
Participants will receive 6-milligram (mg) faricimab intravitreal (IVT) injections, as described in the study arm descriptions for each study phase.
Interventions
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Faricimab
Participants will receive 6-milligram (mg) faricimab intravitreal (IVT) injections, as described in the study arm descriptions for each study phase.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
* 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
* 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)
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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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
Charles Retina Institute
Memphis, Tennessee, United States
Austin Clinical Research LLC
Austin, Texas, United States
Retina & Vitreous of Texas
Bellaire, Texas, United States
Brown Retina Institute
San Antonio, Texas, United States
Retina Center of Texas
Southlake, Texas, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Wagner Kapoor Institute
Norfolk, Virginia, United States
MM Joshi Eye Institute
Hubli, Karnataka, India
PBMA'S H. V. Desai Eye Hospital
Pune, Maharashtra, India
M & J Western Regional Institute of Ophthalmology
Ahmedabad, Rajasthan, India
Sankara Nethralaya
Chennai, Tamil Nadu, India
Aravind Eye Hospital
Madurai, Tamil Nadu, India
Regional Institute of Ophthalmology
Kolkata, West Bengal, India
Post Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh, , India
Nairobi Hospital
Nairobi, , Kenya
City Eye Hospital
Nairobi, , Kenya
Emanuelli Research and Development Center LLC
Arecibo, , Puerto Rico
Countries
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Other Identifiers
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ML43435
Identifier Type: -
Identifier Source: org_study_id
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