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A Phase 3, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal Pegcetacoplan Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

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A Phase 3, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal Pegcetacoplan Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Jan 2025

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At a glance

  • Drugs Pegcetacoplan (Primary)
  • Indications Dry age-related macular degeneration
  • Focus Registrational; Therapeutic Use
  • Acronyms DERBY
  • Sponsors Apellis Pharmaceuticals

    • Most Recent Events

    • 27 Jan 2025 According to an Apellis Pharmaceuticals media release, based on results from Phase 3 OAKS and DERBY studies at 24 months, the Therapeutic Goods Administration (TGA) has approved SYFOVRE (pegcetacoplan) for the every-other-month treatment of adult patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with an intact fovea and when central vision is threatened by GA lesion growth.
    • 20 Sep 2024 According to an Apellis Pharmaceuticals media release, Frank G. Holz, professor and chairman of the department of ophthalmology at the University of Bonn, Germany, is an investigator in OAKS and DERBY studies.
    • 20 Sep 2024 According to an Apellis Pharmaceuticals media release, the company has received a Negative CHMP Opinion on the marketing authorization application of intravitreal Pegcetacoplan for Geographic Atrophy (GA) in the EU Following Re-Examination

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