Treat & Extend Versus Fixed Dosing with Faricimab for Management of Diabetic Macular Edema: a Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial
NCT ID: NCT05610319
Last Updated: 2025-01-08
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE4
446 participants
INTERVENTIONAL
2023-05-01
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema
NCT04432831
A Study to Investigate Aqueous Humor and Multimodal Imaging Biomarkers in Treatment-Naïve Participants With Diabetic Macular Edema Treated With Faricimab
NCT04597918
A Study in Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema to Evaluate the Safety of the Faricimab Prefilled Syringe
NCT05569148
Safety and Efficacy of Faricimab in Patients With NPDR
NCT05681884
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion
NCT04740931
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treat and Extend
Participants randomized to the T\&E Arm will initially receive 6 milligrams (mg) faricimab intravitreal (IVT) injections monthly (28d +/-7 days), with treatment intervals increased/extended, reduced, or maintained based on CST assessments, until week 100.
Faricimab
Faricimab will be administered via intravitreal injection.
Control/Usual Care Arm
Participants in the control arm will receive 6 milligrams (mg) faricimab intravitreal (IVT) injections monthly (28d +/-7 days), for 6 treatments. Afterwards, participants will continue to receive 6mg faricimab IVT every 8 weeks until week 100.
Faricimab
Faricimab will be administered via intravitreal injection.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Faricimab
Faricimab will be administered via intravitreal injection.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Diagnosis of diabetes mellitus (type 1 or type 2).
3. 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.\*\*\*
4. Visual impairment due to DME, with best corrected visual acuity of 80 to 20 letters (Snellen VA 20/25 - 20/400).
5. Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCT and fundus photographs.
6. Hemoglobin A1c must be \<10% within 2 months prior to 1st study treatment.
7. Provide signed informed consent.
Exclusion Criteria
2. High-risk proliferative diabetic retinopathy in the study eye.\*\*
3. Tractional retinal detachment, preretinal fibrosis or visually significant epiretinal membrane involving the macula.
4. Uncontrolled glaucoma (intraocular pressure \>30 with or without medications).
5. Any intravitreal, periocular or implant corticosteroids within 26 weeks (6 months) before day 1 or any use of Iluvien implants.
6. Treatment with Panretinal photocoagulation (PRP) within 12 weeks before day 1.
7. Treatment with macular laser.
8. Any cataract surgery or any other intraocular surgery within 12 weeks before day 1.
9. Macular edema in study eye due to a cause other than DME.
10. 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).
11. 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)
12. 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.)
13. Women of child-bearing potential who are lactating, pregnant, or intending to become pregnant within the next 100 weeks.
14. Current or anticipated incarceration.
15. Terminal illness with expected survival less than 100 weeks.
16. Known hypersensitivity to faricimab or any of the excipients in the faricimab injection.
17. Currently enrolled in a study that does not permit co-enrollment.
18. Unable to obtain informed consent due to language or other operational barriers.
19. Anticipated problems, in the judgment of the site investigator, maintaining compliance with the protocol, including attending study visits, completing assessments or procedures.
20. Prior enrollment in this trial.
21. Other reason to exclude the patient, as approved by the sponsor and site investigator.
22. 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
McMaster University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dr. Varun Chaudhary, MD, FRCS(C)
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Retina Specialists Victoria
Rowville, Victoria, Australia
Lions Eye Institute Limited
Nedlands, Western Australia, Australia
Calgary Retina Consultants
Calgary, Alberta, Canada
Alberta Retina Consultants
Calgary, Alberta, Canada
Retina Surgical Associates
New Westminster, British Columbia, Canada
West Coast Retina
Vancouver, British Columbia, Canada
UBC Eye Centre, Vancouver General Hospital
Vancouver, British Columbia, Canada
The Research Institute of St. Joe's Hamilton
Hamilton, Ontario, Canada
St. Joseph's Healthcare London
London, Ontario, Canada
Retina Institute of Ottawa
Ottawa, Ontario, Canada
Toronto Retina Institute
Toronto, Ontario, Canada
Vitreous Retina Macula Specialists of Toronto
Toronto, Ontario, Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
Bradford Royal Infirmary
Bradford, England, United Kingdom
University Hospitals Bristol-Weston
Bristol, England, United Kingdom
Frimley Health
Frimley, England, United Kingdom
Liverpool University Hospitals
Liverpool, England, United Kingdom
King's College Hospital
London, England, United Kingdom
London North West University
London, England, United Kingdom
Moorfields Eye Hospital
London, England, United Kingdom
The Royal Wolverhampton
Wolverhampton, England, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MR44143
Identifier Type: OTHER
Identifier Source: secondary_id
2022-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.