Treat & Extend Versus Fixed Dosing With Faricimab for Management of Diabetic Macular Edema: A Pra… (NCT05610319) | Clinical Trial Compass
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 States, Australia, Canada446 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.