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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
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study Identification, Study Status, Oversightv20
  2. Trial status: Recruiting to Active, Not Recruiting Study sites: 49 to 46 · Primary and study completion dates: Aug 2026 to Dec 2026v19 Show 2 more changesShow less
    • Study sites: 49 to 46
    • Primary and study completion dates: Aug 2026 to Dec 2026
  3. Site details revised at 48 of 49 sitesv18
  4. Study sites revised (49)v17 See this version in full on ClinicalTrials.gov ↗
  5. Primary completion date: Apr 2024 to Aug 2026 Completion date: Jun 2026 to Aug 2026 · Site details revised at 11 of 49 sitesv16 Show 2 more changesShow less
    • Completion date: Jun 2026 to Aug 2026
    • Site details revised at 11 of 49 sites
Show 14 earlier versionsHide 14 earlier versions
  1. Study sites: 43 to 49v15
  2. Study sites: 34 to 43v14
  3. Site details revised at 3 of 34 sitesv13
  4. Site details revised at 2 of 34 sitesv12
  5. Site details revised at 3 of 34 sitesv11
  6. Study sites: 35 to 34v10
  7. Site details revised at 1 of 35 sitesv9
  8. Study sites: 31 to 35v8
  9. Study sites: 11 to 31v7
  10. Study sites: 8 to 11v6
  11. Study sites: 2 to 8v5
  12. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of May 2023 to May 1, 2023v4 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of May 2023 to May 1, 2023
  13. Phase: Phase 3 to Phase 4 Primary completion date: Mar 2026 to Apr 2024 · Start date: Feb 2023 to May 2023 · Study description shortened, about 444 wordsv3 Show 3 more changesShow less
    • Primary completion date: Mar 2026 to Apr 2024
    • Start date: Feb 2023 to May 2023
    • Study description shortened, about 444 words

    See this version in full on ClinicalTrials.gov ↗

  14. Interventions: Faricimab Injection (Drug) to Faricimab (Drug)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study will assess a pragmatic, treat and extend regimen of faricimab against the standard of a fixed dosing regimen.
Trial Details
NCT Number NCT05610319
Lead Sponsor McMaster University
Collaborators: Hoffmann-La Roche
Conditions Diabetic Macular Edema
Enrollment 446 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov