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Clinical Trials in Australia / NCT05610319
Active, not recruiting Phase 4

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

NCT05610319 · tracked via the Priya Life Science Australia tracker
Phase
Phase 4
Started
2023-05-01
Last updated
2026-04-17

Condition(s) studied

Diabetic Macular Edema

Investigational drug(s) / intervention(s)

Faricimab →

Faricimab: Faricimab will be administered via intravitreal injection.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (46)

FacilityCityRegionStatus
Retinal Consultants Medical Group Inc. Modesto California
Vitreo-Retina Medical Group Sacramento California
University Retina and Macula Associates Oak Forest Illinois
Eye Associates of Northeast Louisiana Dba Haik Humble Eye Center West Monroe Louisiana
Mississippi Retina Associates Jackson Mississippi
Austin Retina Associates Austin Texas
Retina Consultants of Texas Beaumont Texas
Retina & Vitreous of Texas Bellaire Texas
Retina Consultants of Houston, dba Retina Consultants of Texas Bellaire Texas
Valley Retina Institute McAllen Texas
Retina Consultants of Houston, dba Retina Consultants of Texas San Antonio Texas
Eye Clinic Albury Wodonga Albury New South Wales
Nexus Eyecare Blacktown Blacktown New South Wales
Eastern Suburbs Eye Specialists Bondi Junction New South Wales
Retina and Eye Consultants Hurstville New South Wales
Lane Cove Eye Lane Cove New South Wales
South West Retina Liverpool New South Wales
Marsden Eye Specialists Parramatta New South Wales
Strathfield Retina Clinic Strathfield New South Wales
South Eastern Sydney Health Sydney New South Wales
Sydney Retina Sydney New South Wales
Queensland Eye Institute Woolloongabba Queensland
Adelaide Eye & Retina Centre Adelaide South Australia
Hobart Eye Surgeons Hobart Tasmania
Centre for Eye Research Australia East Melbourne Victoria
Retina Specialists Victoria Rowville Victoria
Lions Eye Institute Limited Nedlands Western Australia
Calgary Retina Consultants Calgary Alberta
Alberta Retina Consultants Calgary Alberta
Retina Surgical Associates New Westminster British Columbia
West Coast Retina Vancouver British Columbia
UBC Eye Centre, Vancouver General Hospital Vancouver British Columbia
The Research Institute of St. Joe's Hamilton Hamilton Ontario
St. Joseph's Healthcare London London Ontario
Retina Institute of Ottawa Ottawa Ontario
Toronto Retina Institute Toronto Ontario
Vitreous Retina Macula Specialists of Toronto Toronto Ontario
Maisonneuve-Rosemont Hospital Montreal Quebec
Bradford Royal Infirmary Bradford England
University Hospitals Bristol-Weston Bristol England

+ 6 more sites — see the full list on the official registry below.

More McMaster University trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05610319 on ClinicalTrials.gov ↗ ← All trials in Australia