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A Three-Part, Phase I/II Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Zifibancimig Following Intravitreal Administration of Multiple Ascending Doses and Continuous Delivery From the Port Delivery in Patients With Neovascular Age-Related Macular Degeneration

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Trial Profile

A Three-Part, Phase I/II Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Zifibancimig Following Intravitreal Administration of Multiple Ascending Doses and Continuous Delivery From the Port Delivery in Patients With Neovascular Age-Related Macular Degeneration

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 21 Aug 2024

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At a glance

  • Drugs Zifibancimig (Primary)
  • Indications Choroidal neovascularisation; Wet age-related macular degeneration
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms BURGUNDY
  • Sponsors Roche

    • Most Recent Events

    • 08 Nov 2023 Planned End Date changed from 31 Mar 2027 to 29 Dec 2027.
    • 08 Nov 2023 Planned primary completion date changed from 31 May 2025 to 9 Feb 2026.
    • 23 Dec 2022 According to ClinicalTrials.gov record, protocol has been amended to increase patient number from 200 to 251, treatment arm changed from 5 to 6

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