Treat & Extend Versus Fixed Dosing With Faricimab for Management of Diabetic Macular Edema: A Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial
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)
Change in Best Corrected Visual Acuity — Baseline to Week 100 Change in best corrected visual acuity (3.9 letter non-inferiority margin)
Trial sites (46)
Facility
City
Region
Status
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.
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.
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