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FOCUS: An Open Label First in Human Phase I/II Multicentre Study to Evaluate the Safety, Dose Response and Efficacy of GT005 Administered as a Single Subretinal Injection in Subjects With Macular Atrophy Due to AMD

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Trial Profile

FOCUS: An Open Label First in Human Phase I/II Multicentre Study to Evaluate the Safety, Dose Response and Efficacy of GT005 Administered as a Single Subretinal Injection in Subjects With Macular Atrophy Due to AMD

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 17 Jul 2024

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At a glance

  • Drugs GT 005 (Primary)
  • Indications Dry age-related macular degeneration
  • Focus Adverse reactions; First in man
  • Acronyms FocuS
  • Sponsors Gyroscope Therapeutics

    • Most Recent Events

    • 15 Dec 2023 Planned End Date changed from 19 Jan 2027 to 28 Jun 2024.
    • 15 Dec 2023 Planned primary completion date changed from 23 May 2023 to 28 Jun 2024.
    • 11 Sep 2023 According to a Novartis media release, company has decided to discontinue the drug development of GT005 (PPY988) based on recommendation from the independent Data Monitoring Committee (DMC) following an overall benefit risk assessment of available data from the program studies, which concluded futility criteria had been met.

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