Treat & Extend Versus Fixed Dosing With Faricimab for Management of Diabetic Macular Edema: A Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial

Running, not enrolling · Phase 4

Conditions studied: Diabetic Macular Edema

In brief

This study will assess a pragmatic, treat and extend regimen of faricimab against the standard of a fixed dosing regimen.

Key facts

Study ID

NCT05610319

Run by

McMaster University

People needed

446

Starts

2023-05-01

Expected to finish

2026-12-01

Last updated by the study team

2026-04-17

Who can join

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

You may qualify if…

• Age ≥ 18 years
• Diagnosis of diabetes mellitus (type 1 or type 2).
• Macular thickening secondary to DME (CI-DME) involving the center of the fovea on Optical Coherence Tomography - Central subfield thickness (CST) ≥ 325 μm on Spectralis at screening.***
• Visual impairment due to DME, with best corrected visual acuity of 80 to 20 letters (Snellen VA 20/25 - 20/400).
• Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCT and fundus photographs.
• Hemoglobin A1c must be <10% within 2 months prior to 1st study treatment.
• Provide signed informed consent.

You may not qualify if…

• Active or history of ocular inflammation or suspected/active ocular infection in either eye.
• High-risk proliferative diabetic retinopathy in the study eye.**
• Tractional retinal detachment, preretinal fibrosis or visually significant epiretinal membrane involving the macula.
• Uncontrolled glaucoma (intraocular pressure >30 with or without medications).
• Any intravitreal, periocular or implant corticosteroids within 26 weeks (6 months) before day 1 or any use of Iluvien implants.
• Treatment with Panretinal photocoagulation (PRP) within 12 weeks before day 1.
• Treatment with macular laser.
• Any cataract surgery or any other intraocular surgery within 12 weeks before day 1.
• Macular edema in study eye due to a cause other than DME.
• If clinical exam and/or OCT and/or wide-field fluorescein angiography (WF-FA) suggest that (a) macular edema is considered to be related to ocular surgery such as cataract extraction or (b) if primary cause for macular edema is vitreoretinal interface abnormalities (e.g. a taut posterior hyaloid or epiretinal membrane).
• Any ocular condition is present such that visual acuity loss would not improve from resolution of macular edema in opinion of the investigator (e.g. foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition)
• Any history of ocular conditions that might affect macular edema (e.g. vein occlusion, idiopathic or infectious or non-infectious uveitis, ocular inflammatory disease, neovascular glaucoma etc.)
• Women of child-bearing potential who are lactating, pregnant, or intending to become pregnant within the next 100 weeks.
• Current or anticipated incarceration.
• Terminal illness with expected survival less than 100 weeks.
• Known hypersensitivity to faricimab or any of the excipients in the faricimab injection.
• Currently enrolled in a study that does not permit co-enrollment.
• Unable to obtain informed consent due to language or other operational barriers.
• Anticipated problems, in the judgment of the site investigator, maintaining compliance with the protocol, including attending study visits, completing assessments or procedures.
• Prior enrollment in this trial.
• Other reason to exclude the patient, as approved by the sponsor and site investigator.
• Previous treatment with anti-VEGF and:
• <12 weeks prior to day 1 (washout period).*or,
• Diagnosis of DME is > 2 years of enrollment or,
• Do not have a demonstrated response to anti-VEGF treatment based on clinical discretion.

Where it is running

• Retinal Consultants Medical Group Inc. — Modesto, California, United States
• Vitreo-Retina Medical Group — Sacramento, California, United States
• University Retina and Macula Associates — Oak Forest, Illinois, United States
• Eye Associates of Northeast Louisiana Dba Haik Humble Eye Center — West Monroe, Louisiana, United States
• Mississippi Retina Associates — Jackson, Mississippi, United States
• Austin Retina Associates — Austin, Texas, United States
• Retina Consultants of Texas — Beaumont, Texas, United States
• Retina & Vitreous of Texas — Bellaire, Texas, United States
• Retina Consultants of Houston, dba Retina Consultants of Texas — Bellaire, Texas, United States
• Valley Retina Institute — McAllen, Texas, United States
• Retina Consultants of Houston, dba Retina Consultants of Texas — San Antonio, Texas, United States
• Eye Clinic Albury Wodonga — Albury, New South Wales, Australia
• Nexus Eyecare Blacktown — Blacktown, New South Wales, Australia
• Eastern Suburbs Eye Specialists — Bondi Junction, New South Wales, Australia
• Retina and Eye Consultants — Hurstville, New South Wales, Australia
• Lane Cove Eye — Lane Cove, New South Wales, Australia
• South West Retina — Liverpool, New South Wales, Australia
• Marsden Eye Specialists — Parramatta, New South Wales, Australia
• Strathfield Retina Clinic — Strathfield, New South Wales, Australia
• South Eastern Sydney Health — Sydney, New South Wales, Australia
• Sydney Retina — Sydney, New South Wales, Australia
• Queensland Eye Institute — Woolloongabba, Queensland, Australia
• Adelaide Eye & Retina Centre — Adelaide, South Australia, Australia
• Hobart Eye Surgeons — Hobart, Tasmania, Australia
• Centre for Eye Research Australia — East Melbourne, Victoria, Australia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.