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A Global, Phase III, Double Blind, Randomized Controlled Study to Compare the Efficacy, Safety & Immunogenicity of LUBT010 with Lucentis in Patients with Neovascular Age-Related Macular Degeneration

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Trial Profile

A Global, Phase III, Double Blind, Randomized Controlled Study to Compare the Efficacy, Safety & Immunogenicity of LUBT010 with Lucentis in Patients with Neovascular Age-Related Macular Degeneration

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Aug 2024

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At a glance

  • Drugs Ranibizumab (Primary)
  • Indications Wet age-related macular degeneration
  • Focus Registrational; Therapeutic Use
  • Sponsors Lupin

    • Most Recent Events

    • 07 Aug 2024 Status changed from recruiting to completed.
    • 05 Aug 2024 According to a Lupin media release, the data from this Phase 3 study will be part application for marketing approval with the U.S. FDA and the European Medicines Agency (EMA) and company will be filing marketing applications for LUBT010 in all major global markets this year.
    • 05 Aug 2024 Primary endpoint has been met. (Mean change in BCVA from baseline in the study eye at the end of 12 months, assessed with the ETDRS chart.), according to a Lupin media release.

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