A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD

Study acronym: Sightspire
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Secondary endpoints revised (14)
    • Site details revised at 1 of 61 sites
  2. Study sites: 60 to 61
    • Eligibility criteria expanded, about 46 words
    • Secondary endpoints: details revised at 3 of 14 entries
  3. Study sites: 59 to 60v21
  4. Re-verified, no change to tracked fieldsv20
  5. Study sites: 57 to 59v19
  6. Primary and study completion dates pushed to Nov 15, 2028
    • Study sites: 56 to 57
    v18
  7. Trial sites expanded: 53 → 56 locationsv17
  8. Trial sites expanded: 45 → 53 locationsv16
  9. Study sites: 34 to 45v15
  10. Study sites: 28 to 34v14
  11. Study sites: 13 to 28v13
  12. Study sites: 10 to 13
    • Start date changed from estimate of Nov 30, 2025 to Nov 27, 2025
    v12
  13. Study sites: 3 to 10
    • Start date: Nov 18, 2025 to Nov 30, 2025
    v11
  14. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    v10
  15. 5 versions Re-verified since Jun 12, 2025, no change to tracked fieldsv5-v9
  16. Start date: Sep 1, 2025 to Nov 18, 2025v4
  17. Start date: Jun 19, 2025 to Sep 1, 2025
    • Primary completion date: Jul 10, 2028 to Sep 12, 2028
    • Study completion date: Aug 9, 2028 to Oct 12, 2028
    v3
  18. Re-verified, no change to tracked fieldsv2
  19. 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
371 trials monitored
See 27 trials at risk
The purpose of this study is to evaluate the effectiveness, safety, and PROs of the port delivery system with ranibizumab 100 milligrams/milliliters (mg/mL) refilled every 36 weeks (Q36W) in participants with nAMD.
Trial Details
NCT Number NCT06847542
Lead Sponsor Hoffmann-La Roche
Collaborators: Genentech, Inc.
Conditions
(from sponsor)		 Neovascular Age-related Macular Degeneration
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov