Clinical Trial

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

Study acronym: INSITE-DME
Active, Not Recruiting Phase 4
View on ClinicalTrials.gov →
Summary
This study will assess a pragmatic, treat and extend regimen of faricimab against the standard of a fixed dosing regimen.
Protocol Amendment History 19 amendments
This ClinicalTrials.gov record has been amended 19 times since 2022-11-02; most recent amendment 2026-04-14.
Status change: Recruiting → Active, Not Recruiting 2025-01-06
Status change: Not Yet Recruiting → Recruiting 2023-05-04
Trial Details
NCT Number NCT05610319
Lead Sponsor McMaster University
Collaborators: Hoffmann-La Roche
Conditions Diabetic Macular Edema
Enrollment 446 participants
Start Date 2023-05-01
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-17