A Study to Investigate Faricimab Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema

Study acronym: ELEVATUM
StatusActive, Not Recruiting
PhasePhase 4
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv49
  2. Study sites revised (43)v48
  3. Re-verified, no change to tracked fieldsv47
  4. Primary and study completion dates: Feb 28, 2027 to Jan 26, 2027v46
  5. 2 versions Re-verified since Jun 3, 2025, no change to tracked fieldsv44-v45
Show 42 earlier versionsHide 42 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 49 to 43
    v43
  2. Primary and study completion dates: Jan 31, 2027 to Feb 28, 2027
    • Site details revised at 1 of 49 sites
    v42
  3. Study sites: 51 to 49v41
  4. Primary and study completion dates: Nov 30, 2026 to Jan 31, 2027v40
  5. 2 versions Re-verified since Oct 21, 2024, no change to tracked fieldsv38-v39
  6. Study sites revised (51)v37
  7. 2 versions Re-verified since Jul 22, 2024, no change to tracked fieldsv35-v36
  8. Site details revised at 2 of 51 sitesv34
  9. Site details revised at 4 of 51 sitesv33
  10. 2 versions Re-verified since Apr 8, 2024, no change to tracked fieldsv31-v32
  11. Study sites: 50 to 51v30
  12. Study sites: 49 to 50v29
  13. Study sites: 47 to 49v28
  14. Re-verified, no change to tracked fieldsv27
  15. Study sites: 44 to 47v26
  16. Re-verified, no change to tracked fieldsv25
  17. Site details revised at 2 of 44 sitesv24
  18. Re-verified, no change to tracked fieldsv23
  19. Primary and study completion dates: Jun 30, 2024 to Nov 30, 2026v22 Show 6 more changesShow less
    • Primary endpoints: 1 to 3
    • Enrollment target: 168 to 218
    • Eligibility criteria expanded, about 246 words
    • Secondary endpoints revised (10)
    • Site details revised at 2 of 44 sites
    • Study arms: 1 to 2
  20. Site details revised at 2 of 44 sitesv21
  21. Site details revised at 3 of 44 sitesv20
  22. Study sites revised (44)v19
  23. Re-verified, no change to tracked fieldsv18
  24. Enrollment target: 120 to 168
    • Primary and study completion dates: Mar 28, 2024 to Jun 30, 2024
    • Eligibility criteria expanded, about 12 words
    • Site details revised at 2 of 44 sites
    v17
  25. Site details revised at 1 of 44 sitesv16
  26. Re-verified, no change to tracked fieldsv15
  27. Study sites: 41 to 44v14
  28. Study sites: 39 to 41v13
  29. Study sites: 37 to 39v12
  30. 2 versions Re-verified since Sep 16, 2022, no change to tracked fieldsv10-v11
  31. Study sites: 36 to 37v9
  32. Study sites: 28 to 36v8
  33. Study sites: 21 to 28v7
  34. Study sites: 17 to 21v6
  35. Study sites: 8 to 17v5
  36. Study sites: 4 to 8v4
  37. Study sites: 1 to 4
    • Start date changed from estimate of Mar 10, 2022 to Feb 28, 2022
    v3
  38. Trial status: Not Yet Recruiting to Recruiting
    • Study site revised
    v2
  1. Study First Submitted
  • 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.
Roche/Genentech
369 trials monitored
See 29 trials at risk
This study is designed to investigate treatment response in treatment-naïve underrepresented patients with diabetic macular edema (DME) who are treated with faricimab. The study population will consist of participants ≥18 years of age who self-identify as Black/African American, Hispanic/Latino American, or Native American/Alaska Native/Native Hawaiian or other Pacific Islander; in addition, a cohort of Asian Indian participants will be enrolled in India.
Trial Details
NCT Number NCT05224102
Lead Sponsor Genentech, Inc.
Conditions
(from sponsor)		 Diabetic Macular Edema
Enrollment 218 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov