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A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With nAMD

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Trial Profile

A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With nAMD

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Nov 2023

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At a glance

  • Drugs RGX 314 (Primary) ; Aflibercept
  • Indications Wet age-related macular degeneration
  • Focus Registrational; Therapeutic Use
  • Acronyms ASCENT
  • Sponsors AbbVie; REGENXBIO
  • Most Recent Events

    • 08 Nov 2023 According to a REGENXBIO media release, this trial expected to support global regulatory submissions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in late 2025 through the first half of 2026.
    • 18 May 2023 Planned End Date changed from 1 Dec 2024 to 1 Dec 2025.
    • 18 May 2023 Planned primary completion date changed from 1 Apr 2024 to 1 Feb 2025.
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