Clinical trial NCT05610319: Treat & Extend Versus Fixed Dosing with Faricimab for Management of Diabetic Macular Edema: a Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial
Official title: Treat & Extend Versus Fixed Dosing with Faricimab for Management of Diabetic Macular Edema: a Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Diabetic Macular Edema
Keywords: Treat and Extend
Faricimab
Anti-VEGF
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2022-11-09
Enrollment: 446
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-armed, parallel, non-inferiority randomized controlled trial
Primary purpose: TREATMENT

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


Eligibility criteria: 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 outcomes:
measure: Change in Best Corrected Visual Acuity
timeFrame: Baseline to Week 100
Secondary outcomes:
measure: Decrease in Diabetic Retinopathy Severity Score
timeFrame: Baseline to Week 100
measure: Decrease in Diabetic Retinopathy Severity Score
timeFrame: Baseline to Week 100
measure: Change in Central Subfield Thickness
timeFrame: Baseline to Week 100
measure: Change in Vision Related Quality of Life
timeFrame: Baseline to Week 100
measure: Change in Letters of Vision
timeFrame: Baseline to Week 100
measure: Absence of Diabetic Macular Edema
timeFrame: Week 100
measure: Absence of Intraretinal Fluid (IRF)
timeFrame: Week 100
measure: Dosing Interval
timeFrame: Week 100
measure: Presence of Safety Outcomes
timeFrame: Baseline to Week 100
Other outcomes:
Locations:
city: Modesto
country: United States
facility: Retinal Consultants Medical Group Inc.
state: California
city: Sacramento
country: United States
facility: Vitreo-Retina Medical Group
state: California
city: Oak Forest
country: United States
facility: University Retina and Macula Associates
state: Illinois
city: West Monroe
country: United States
facility: Eye Associates of Northeast Louisiana Dba Haik Humble Eye Center
state: Louisiana
city: Jackson
country: United States
facility: Mississippi Retina Associates
state: Mississippi
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Beaumont
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Bellaire
country: United States
facility: Retina & Vitreous of Texas
state: Texas
city: Bellaire
country: United States
facility: Retina Consultants of Houston, dba Retina Consultants of Texas
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute
state: Texas
city: San Antonio
country: United States
facility: Retina Consultants of Houston, dba Retina Consultants of Texas
state: Texas
city: Albury
country: Australia
facility: Eye Clinic Albury Wodonga
state: New South Wales
city: Blacktown
country: Australia
facility: Nexus Eyecare Blacktown
state: New South Wales
city: Bondi Junction
country: Australia
facility: Eastern Suburbs Eye Specialists
state: New South Wales
city: Hurstville
country: Australia
facility: Retina and Eye Consultants
state: New South Wales
city: Lane Cove
country: Australia
facility: Lane Cove Eye
state: New South Wales
city: Liverpool
country: Australia
facility: South West Retina
state: New South Wales
city: Parramatta
country: Australia
facility: Marsden Eye Specialists
state: New South Wales
city: Strathfield
country: Australia
facility: Strathfield Retina Clinic
state: New South Wales
city: Sydney
country: Australia
facility: South Eastern Sydney Health
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Retina
state: New South Wales
city: Woolloongabba
country: Australia
facility: Queensland Eye Institute
state: Queensland
city: Adelaide
country: Australia
facility: Adelaide Eye & Retina Centre
state: South Australia
city: Hobart
country: Australia
facility: Hobart Eye Surgeons
state: Tasmania
city: East Melbourne
country: Australia
facility: Centre for Eye Research Australia
state: Victoria
city: Rowville
country: Australia
facility: Retina Specialists Victoria
state: Victoria
city: Nedlands
country: Australia
facility: Lions Eye Institute Limited
state: Western Australia
city: Calgary
country: Canada
facility: Calgary Retina Consultants
state: Alberta
city: Calgary
country: Canada
facility: Alberta Retina Consultants
state: Alberta
city: New Westminster
country: Canada
facility: Retina Surgical Associates
state: British Columbia
city: Vancouver
country: Canada
facility: West Coast Retina
state: British Columbia
city: Vancouver
country: Canada
facility: UBC Eye Centre, Vancouver General Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: The Research Institute of St. Joe's Hamilton
state: Ontario
city: London
country: Canada
facility: St. Joseph's Healthcare London
state: Ontario
city: Ottawa
country: Canada
facility: Retina Institute of Ottawa
state: Ontario
city: Toronto
country: Canada
facility: Toronto Retina Institute
state: Ontario
city: Toronto
country: Canada
facility: Vitreous Retina Macula Specialists of Toronto
state: Ontario
city: Montréal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
state: England
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol-Weston
state: England
city: Frimley
country: United Kingdom
facility: Frimley Health
state: England
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals
state: England
city: London
country: United Kingdom
facility: King's College Hospital
state: England
city: London
country: United Kingdom
facility: London North West University
state: England
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
state: England
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton
state: England
Study officials:
affiliation: McMaster University
name: Dr. Varun Chaudhary, MD, FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References: