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

NCT05610319 | Active Not Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 2022-01MR44143
• Study Type: interventional
• Target: 446
• Locations: 4 countries
• Sites: 46

Brief Summary

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

Conditions

Diabetic Macular Edema

Keywords

Treat and Extend; Faricimab; Anti-VEGF

Outcome Measures

Primary Outcomes (1)

• Change in Best Corrected Visual Acuity

  Change in best corrected visual acuity (3.9 letter non-inferiority margin)

  Baseline to Week 100

Secondary Outcomes (9)

• Decrease in Diabetic Retinopathy Severity Score

  Baseline to Week 100

• Decrease in Diabetic Retinopathy Severity Score

  Baseline to Week 100

• Change in Central Subfield Thickness

  Baseline to Week 100

• Change in Vision Related Quality of Life

  Baseline to Week 100

• Change in Letters of Vision

  Baseline to Week 100

Study Arms (2)

Treat and Extend

EXPERIMENTAL

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.

Drug: Faricimab

Control/Usual Care Arm

OTHER

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.

Drug: Faricimab

Interventions

Faricimab DRUG

Faricimab will be administered via intravitreal injection.

Control/Usual Care Arm; Treat and Extend

Eligibility Criteria

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

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.

Sponsors & Collaborators

• McMaster University: lead
• Hoffmann-La Roche: collaborator

Study Sites (46)

Retinal Consultants Medical Group Inc.

Modesto, California, 95356, United States

Location

Vitreo-Retina Medical Group

Sacramento, California, 95825, United States

Location

University Retina and Macula Associates

Oak Forest, Illinois, 60452, United States

Location

Eye Associates of Northeast Louisiana Dba Haik Humble Eye Center

West Monroe, Louisiana, 71291, United States

Location

Mississippi Retina Associates

Jackson, Mississippi, 39202, United States

Location

Austin Retina Associates

Austin, Texas, 78705, United States

Location

Retina Consultants of Texas

Beaumont, Texas, 77707, United States

Location

Retina & Vitreous of Texas

Bellaire, Texas, 77401, United States

Location

Retina Consultants of Houston, dba Retina Consultants of Texas

Bellaire, Texas, 77401, United States

Location

Valley Retina Institute

McAllen, Texas, 78503, United States

Location

Retina Consultants of Houston, dba Retina Consultants of Texas

San Antonio, Texas, 78240, United States

Location

Eye Clinic Albury Wodonga

Albury, New South Wales, 2640, Australia

Location

Nexus Eyecare Blacktown

Blacktown, New South Wales, Australia

Location

Eastern Suburbs Eye Specialists

Bondi Junction, New South Wales, 2022, Australia

Location

Retina and Eye Consultants

Hurstville, New South Wales, 2220, Australia

Location

Lane Cove Eye

Lane Cove, New South Wales, 2066, Australia

Location

South West Retina

Liverpool, New South Wales, 2170, Australia

Location

Marsden Eye Specialists

Parramatta, New South Wales, 2150, Australia

Location

Strathfield Retina Clinic

Strathfield, New South Wales, 2135, Australia

Location

South Eastern Sydney Health

Sydney, New South Wales, 2000, Australia

Location

Sydney Retina

Sydney, New South Wales, 2000, Australia

Location

Queensland Eye Institute

Woolloongabba, Queensland, 4012, Australia

Location

Adelaide Eye & Retina Centre

Adelaide, South Australia, 5000, Australia

Location

Hobart Eye Surgeons

Hobart, Tasmania, 7008, Australia

Location

Centre for Eye Research Australia

East Melbourne, Victoria, 3002, Australia

Location

Retina Specialists Victoria

Rowville, Victoria, 3178, Australia

Location

Lions Eye Institute Limited

Nedlands, Western Australia, 6009, Australia

Location

Calgary Retina Consultants

Calgary, Alberta, T2H 0C8, Canada

Location

Alberta Retina Consultants

Calgary, Alberta, T5H 0X5, Canada

Location

Retina Surgical Associates

New Westminster, British Columbia, V3L 5H1, Canada

Location

West Coast Retina

Vancouver, British Columbia, V5Z 1K1, Canada

Location

UBC Eye Centre, Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

The Research Institute of St. Joe's Hamilton

Hamilton, Ontario, L8G 5E4, Canada

Location

St. Joseph's Healthcare London

London, Ontario, N6A 4V2, Canada

Location

Retina Institute of Ottawa

Ottawa, Ontario, K2B 7E9, Canada

Location

Toronto Retina Institute

Toronto, Ontario, M3C 0G9, Canada

Location

Vitreous Retina Macula Specialists of Toronto

Toronto, Ontario, M8X 2X3, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Bradford Royal Infirmary

Bradford, England, United Kingdom

Location

University Hospitals Bristol-Weston

Bristol, England, United Kingdom

Location

Frimley Health

Frimley, England, United Kingdom

Location

Liverpool University Hospitals

Liverpool, England, United Kingdom

Location

King's College Hospital

London, England, United Kingdom

Location

London North West University

London, England, United Kingdom

Location

Moorfields Eye Hospital

London, England, United Kingdom

Location

The Royal Wolverhampton

Wolverhampton, England, United Kingdom

Location

MeSH Terms

Interventions

faricimab

Study Officials

• Dr. Varun Chaudhary, MD, FRCS(C)

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-armed, parallel, non-inferiority randomized controlled trial

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 9, 2022
• Study Start: May 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (11); AU (16); CA (11); GB (8)