A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)

Study acronym: Belvedere
StatusRecruiting
PhasePhase 4
Started

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Record History

The 50 most recent of 56 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Interventions: LUCENTIS (Ranibizumab Injection) (Drug), PDS Implant With Ranibizumab 100 mg/ml (Device) to LUCENTIS (Ranibizumab Injection) (Drug), PDS Implant With Ranibizumab 100 mg/ml (Device)
    • Eligibility criteria expanded, about 88 words
  2. Study sites revised (52)v55
  3. Primary completion moved earlier from Sep 30, 2027 to Jul 30, 2027
    • Study completion moved earlier from Oct 29, 2027 to Aug 31, 2027
    • Site details revised at 1 of 52 sites
    v54
  4. Study sites: 51 to 52v53
  5. Study sites: 50 to 51v52
  6. Primary completion moved earlier from Mar 31, 2028 to Sep 30, 2027
    • Study completion moved earlier from Apr 30, 2028 to Oct 29, 2027
    • Study sites revised (50)
    v51
  7. Re-verified, no change to tracked fieldsv50
  8. Site details revised at 4 of 50 sitesv49
  9. Site details revised at 1 of 50 sitesv48
  10. 4 versions Re-verified since Oct 23, 2025, no change to tracked fieldsv44-v47
  11. Interventions: LUCENTIS (ranibizumab injection) (Drug), SUSVIMO PDS Implant (Device) to LUCENTIS (Ranibizumab Injection) (Drug), PDS Implant With Ranibizumab 100 mg/ml (Device)
    • Eligibility criteria expanded, about 120 words
    v43
  12. Re-verified, no change to tracked fieldsv42
  13. Primary completion date: Apr 30, 2027 to Mar 31, 2028
    • Study completion date: Apr 30, 2027 to Apr 30, 2028
    v41
  14. Re-verified, no change to tracked fieldsv40
  15. Site details revised at 1 of 50 sitesv39
  16. Re-verified, no change to tracked fieldsv38
  17. Site details revised at 1 of 50 sitesv37
  18. Study sites: 49 to 50v36
  19. Study sites: 42 to 49v35
  20. 2 versions Re-verified since Nov 15, 2024, no change to tracked fieldsv33-v34
  21. Primary endpoint revisedv32 Show 6 more changesShow less
    • Enrollment target: 185 to 188
    • Study sites: 34 to 42
    • Interventions: LUCENTIS (ranibizumab injection) (Drug), SUSVIMO Port Delivery System with ranibizumab (PDS) (Device) to LUCENTIS (ranibizumab injection) (Drug), SUSVIMO PDS Implant (Device)
    • Eligibility criteria shortened, about 10 words
    • Secondary endpoints: 9 to 12
    • Study title revised
  22. Enrollment target: 58 to 185v31 Show 6 more changesShow less
    • Primary and study completion dates: Jan 31, 2024 to Apr 30, 2027
    • Primary endpoints: 2 to 1
    • Interventions: LUCENTIS (ranibizumab injection) (Drug), SUSVIMO (ranibizumab injection) (Device) to LUCENTIS (ranibizumab injection) (Drug), SUSVIMO Port Delivery System with ranibizumab (PDS) (Device)
    • Eligibility criteria shortened, about 182 words
    • Secondary endpoints: 16 to 9
    • Study title shortened, about 12 words
  23. Re-verified, no change to tracked fieldsv30
  24. Site details revised at 2 of 34 sitesv29
  25. Re-verified, no change to tracked fieldsv28
  26. Site details revised at 1 of 34 sitesv27
  27. Site details revised at 2 of 34 sitesv26
  28. Site details revised at 2 of 34 sitesv25
  29. 2 versions Re-verified since May 15, 2023, no change to tracked fieldsv23-v24
  30. Study sites revised (34)v22
  31. Enrollment target: 200 to 58v21
  32. Study sites: 33 to 34v20
  33. Re-verified, no change to tracked fieldsv19
  34. Site details revised at 6 of 33 sitesv18
  35. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 33 of 33 sites
    v17
  36. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 33 of 33 sites
    v16
  37. Re-verified, no change to tracked fieldsv15
  38. Study sites revised (33)v14
  39. Site details revised at 1 of 33 sitesv13
  40. Re-verified, no change to tracked fieldsv12
  41. Study sites: 32 to 33v11
  42. Re-verified, no change to tracked fieldsv10
  43. Site details revised at 1 of 32 sitesv9
  44. Study sites: 20 to 32v8
  45. Study sites: 17 to 20
    • Study completion date: Mar 31, 2024 to Jan 31, 2024
    v7
  • 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 will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).
Trial Details
NCT Number NCT04853251
Lead Sponsor Genentech, Inc.
Conditions
(from sponsor)		 Neovascular Age-related Macular Degeneration
Enrollment 188 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov