A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration

StatusRecruiting
PhasePhase 3
SponsorAmgen
Started

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Record History

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  1. Minor Trial sites expanded: 69 → 81 locations
  2. Minor Trial sites expanded: 64 → 69 locations
  3. Minor Trial sites expanded: 58 → 64 locations
    • Eligibility criteria expanded, about 18 words
  4. Minor Trial sites expanded: 53 → 58 locationsv9
  5. Minor Study sites: 51 to 53v8
  6. Minor Trial sites expanded: 36 → 51 locationsv7
  7. Minor Trial sites expanded: 29 → 36 locationsv6
  8. Minor Study sites: 27 to 29
    • Primary completion date: Aug 3, 2027 to Jul 31, 2027
    • Study completion date: Jan 17, 2028 to Jan 12, 2028
    v5
  9. Minor Trial sites expanded: 20 → 27 locations
    • Primary completion date: Jul 31, 2027 to Aug 3, 2027
    • Study completion date: Jan 12, 2028 to Jan 17, 2028
    v4
  10. Minor Study sites: 18 to 20v3
  11. Notable Recruitment openedv2 Show 4 more changesShow less
    • Trial sites expanded: 0 → 18 locations
    • Primary completion date: Aug 3, 2027 to Jul 31, 2027
    • Study completion date: Jan 17, 2028 to Jan 12, 2028
    • Start date changed from estimate of Jun 1, 2026 to May 27, 2026
  12. Minor 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.
169 trials monitored
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The aim of this trial is to demonstrate similarity in efficacy between ABP 938 8 mg and aflibercept (US) 8 mg by evaluating the change in best corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (nAMD)
Trial Details
NCT Number NCT07614776
Lead Sponsor Amgen
Conditions
(from sponsor)
Neovascular Age-related Macular Degeneration, nAMD
Enrollment 304 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov