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Study of Zifibancimig in Participants With Neovascular Age-related Macular Degeneration

Study acronym: BURGUNDY
StatusCompleted
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 66 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial completed Study sites: 38 to 37v66 Show 1 more changeShow less
    • Study sites: 38 to 37
  2. Primary completion pushed from Mar 10, 2026 to Aug 25, 2026 Primary completion moved earlier from Aug 1, 2026 to Mar 10, 2026v65 Show 1 more changeShow less
    • Primary completion moved earlier from Aug 1, 2026 to Mar 10, 2026
  3. Study sites: 39 to 38 Primary completion date changed from estimate of Aug 1, 2026 to Mar 10, 2026 · Completion date: Aug 1, 2026 to Aug 25, 2026v64 Show 2 more changesShow less
    • Primary completion date changed from estimate of Aug 1, 2026 to Mar 10, 2026
    • Completion date: Aug 1, 2026 to Aug 25, 2026
  4. Trial sites reduced: 48 → 39 locationsv63
  5. Study sites: 52 to 48v62
Show 45 earlier versionsHide 45 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 251 to confirmed 177 · Study sites: 53 to 52 · Primary completion date: Feb 11, 2027 to Aug 1, 2026 · 3 morev61 Show 6 more changesShow less
    • Enrollment target: estimated 251 to confirmed 177
    • Study sites: 53 to 52
    • Primary completion date: Feb 11, 2027 to Aug 1, 2026
    • Completion date: Dec 30, 2028 to Aug 1, 2026
    • Secondary endpoints revised (8)
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv60
  3. Site details revised at 1 of 53 sitesv59
  4. Site details revised at 3 of 53 sitesv58
  5. Primary endpoints revised (11) Study sites: 50 to 53 · Eligibility criteria revised · Secondary endpoints revised (8)v57 Show 3 more changesShow less
    • Study sites: 50 to 53
    • Eligibility criteria revised
    • Secondary endpoints revised (8)

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites: 48 to 50v56
  7. Study sites: 47 to 48v55
  8. Primary completion date: Feb 9, 2026 to Feb 11, 2027 Completion date: Dec 29, 2027 to Dec 30, 2028v54 Show 1 more changeShow less
    • Completion date: Dec 29, 2027 to Dec 30, 2028
  9. Study sites: 44 to 47v53
  10. Study sites: 43 to 44 Eligibility criteria expanded, about 5 wordsv52 Show 1 more changeShow less
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites: 29 to 43v51
  12. Site details revised at 1 of 29 sitesv50
  13. Site details revised at 2 of 29 sites Eligibility criteria expanded, about 5 wordsv49 Show 1 more changeShow less
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  14. Study sites: 28 to 29v48
  15. Phase: Phase 1 to Phase 1/2 Study sites: 20 to 28v47 Show 1 more changeShow less
    • Study sites: 20 to 28
  16. Study sites: 19 to 20v46
  17. Study sites: 16 to 19v45
  18. Study sites: 12 to 16v44
  19. Study sites: 11 to 12v43
  20. Study sites: 10 to 11v42
  21. 3 versions Re-verified since Dec 4, 2023, no change to tracked fieldsv39-v41
  22. Primary completion date: May 31, 2025 to Feb 9, 2026 Completion date: Mar 31, 2027 to Dec 29, 2027 · Eligibility criteria expanded, about 16 words · Secondary endpoints: details revised at 2 of 8 entriesv38 Show 3 more changesShow less
    • Completion date: Mar 31, 2027 to Dec 29, 2027
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 2 of 8 entries

    See this version in full on ClinicalTrials.gov ↗

  23. 5 versions Re-verified since May 4, 2023, no change to tracked fieldsv33-v37
  24. Interventions: Port Delivery Platform (Device), RO7250284 (Drug), Ranibizumab (Drug) to Port Delivery Platform (Device), Ranibizumab (Drug), Zifibancimig (Drug) Secondary endpoints revised (8)v32 Show 1 more changeShow less
    • Secondary endpoints revised (8)

    See this version in full on ClinicalTrials.gov ↗

  25. 2 versions Re-verified since Jan 17, 2023, no change to tracked fieldsv30-v31
  26. Enrollment target: 200 to 251 Primary completion date: Nov 19, 2025 to May 31, 2025 · Completion date: Nov 19, 2025 to Mar 31, 2027 · Eligibility criteria expanded, about 39 words · 2 morev29 Show 5 more changesShow less
    • Primary completion date: Nov 19, 2025 to May 31, 2025
    • Completion date: Nov 19, 2025 to Mar 31, 2027
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints revised (8)
    • Study arms: 5 to 6

    See this version in full on ClinicalTrials.gov ↗

  27. Enrollment target: 251 to 200 Eligibility criteria shortened, about 38 words · Secondary endpoints revised (8) · Study arms: 6 to 5v28 Show 3 more changesShow less
    • Eligibility criteria shortened, about 38 words
    • Secondary endpoints revised (8)
    • Study arms: 6 to 5

    See this version in full on ClinicalTrials.gov ↗

  28. Secondary endpoints revised (8) Site details revised at 1 of 10 sites · Eligibility criteria expanded, about 3 wordsv27 Show 2 more changesShow less
    • Site details revised at 1 of 10 sites
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  29. Primary endpoints revised (11) Site details revised at 1 of 10 sitesv26 Show 1 more changeShow less
    • Site details revised at 1 of 10 sites

    See this version in full on ClinicalTrials.gov ↗

  30. Primary endpoints revised (11) Enrollment target: 200 to 251 · Eligibility criteria expanded, about 40 words · Secondary endpoints revised (8) · 1 morev25 Show 4 more changesShow less
    • Enrollment target: 200 to 251
    • Eligibility criteria expanded, about 40 words
    • Secondary endpoints revised (8)
    • Study arms: 5 to 6

    See this version in full on ClinicalTrials.gov ↗

  31. Primary endpoints: 10 to 11 Enrollment target: 190 to 200 · Interventions: RO7250284 (Drug), Ranibizumab (Drug) to Port Delivery Platform (Device), RO7250284 (Drug), Ranibizumab (Drug) · Eligibility criteria expanded, about 122 words · 1 morev24 Show 4 more changesShow less
    • Enrollment target: 190 to 200
    • Interventions: RO7250284 (Drug), Ranibizumab (Drug) to Port Delivery Platform (Device), RO7250284 (Drug), Ranibizumab (Drug)
    • Eligibility criteria expanded, about 122 words
    • Secondary endpoints revised (8)

    See this version in full on ClinicalTrials.gov ↗

  32. Re-verified, no change to tracked fieldsv23
  33. Study sites: 11 to 10v22
  34. Site details revised at 5 of 11 sitesv21
  35. Study sites: 10 to 11v20
  36. Enrollment target: 50 to 190 Interventions: RO7250284 (Drug) to RO7250284 (Drug), Ranibizumab (Drug) · Study arms: 3 to 5v19 Show 2 more changesShow less
    • Interventions: RO7250284 (Drug) to RO7250284 (Drug), Ranibizumab (Drug)
    • Study arms: 3 to 5
  37. Study sites: 11 to 10v18
  38. Study sites: 10 to 11v17
  • 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.
Roche/Genentech
366 trials monitored
See 33 trials at risk
This is a first in-human study to investigate the safety, tolerability and efficacy of zifibancimig administered through intravitreal (IVT) injections and via the port delivery (PD) implant in participants with neovascular age-related macular degeneration (nAMD).
Trial Details
NCT Number NCT04567303
Lead Sponsor Hoffmann-La Roche
Conditions Macular Degeneration
Enrollment 177 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov