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A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity Between SB11 and Lucentis in Subjects With Neovascular Age-related Macular Degeneration

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Trial Profile

A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity Between SB11 and Lucentis in Subjects With Neovascular Age-related Macular Degeneration

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Mar 2023

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At a glance

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

    • Most Recent Events

    • 01 Mar 2023 Results assessing efficacy, safety, immunogenicity and pharmacokinetics (PK) of ranibizumab biosimilar SB11 compared with the reference ranibizumab (RBZ) in patients with neovascular age-related macular degeneration published in the British Journal of Ophthalmology
    • 01 Feb 2023 Results of post hoc analysis assessing the association of immunogenicity to ranibizumab products (SB11 and RBZ) with efficacy, safety, and pharmacokinetics, published in the JAMA Ophthalmology.
    • 27 Sep 2022 According to Samsung Bioepis media release, post hoc analysis data from this trial will be presented at the American Academy of Ophthalmology (AAO) 2022 Annual Meeting

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