Active — Not RecruitingPhase 4

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

United States446 participantsStarted 2023-05-01

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Change in Best Corrected Visual Acuity

Timeframe: Baseline to Week 100

NCT IDNCT05610319

SponsorMcMaster University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.