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

Phase 4

Active, not recruiting

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Faricimab

• Registration Number: NCT05610319
• Lead Sponsor: McMaster University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-02
• Study First Posted: 2022-11-09
• Study Start: 2023-05-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 446

Inclusion Criteria

1. Age ≥ 18 years
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

1. Active or history of ocular inflammation or suspected/active ocular infection in either eye.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control/Usual Care Arm	Faricimab	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.
Treat and Extend	Faricimab	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.

Primary Outcome Measures

Name	Time	Method
Change in Best Corrected Visual Acuity	Baseline to Week 100	Change in best corrected visual acuity (3.9 letter non-inferiority margin)

Secondary Outcome Measures

Name	Time	Method
Absence of Diabetic Macular Edema	Week 100	Absence of diabetic macular edema in the study eye
Presence of Safety Outcomes	Baseline to Week 100	Safety outcomes (ocular and systemic AEs and SAEs)
Change in Letters of Vision	Baseline to Week 100	Gaining or losing ≥5, ≥10, or ≥15 letters of vision
Decrease in Diabetic Retinopathy Severity Score	Baseline to Week 100	A 3-step improvement in diabetic retinopathy severity score
Absence of Intraretinal Fluid (IRF)	Week 100	Absence of intraretinal fluid (IRF) in the study eye
Change in Central Subfield Thickness	Baseline to Week 100	Change in central subfield thickness on OCT
Change in Vision Related Quality of Life	Baseline to Week 100	Change in vision-related quality of life (VFQ-25)
Dosing Interval	Week 100	Dosing interval at week 100

Trial Locations

Locations (45)

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; 🇺🇸 San Antonio, Texas, United States

Valley Retina Institute; 🇺🇸 McAllen, 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; 🇨🇦 Montréal, 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