CLNP023E12201: PoC study of Iptacopan in early & intermediate age-related macular degeneration (AMD)

  • Research type

    Research Study

  • Full title

    A randomized, participant and investigator masked, placebo-controlled, multicenter, proof-of-concept study to assess the safety and efficacy of LNP023 (Iptacopan) in patients with early and intermediate age-related macular degeneration

  • IRAS ID

    1007087

  • Contact name

    Florent Revel

  • Contact email

    florent.revel@novartis.com

  • Sponsor organisation

    Novartis Pharma AG

  • Eudract number

    2021-001797-31

  • Clinicaltrials.gov Identifier

    NCT05230537

  • Research summary

    This is a study in participants with an eye disease called age-related macular degeneration (AMD). The purpose of the study is to find out if a medicine named Iptacopan can preserve vision by stopping the progression of the early and intermediate stages of the disease to the late stage of AMD. People can participate if they are at least 50 years old and if one eye is diagnosed with early or intermediate AMD and the other is treated with anti-VEGF therapy for wet (neovascular) AMD. During the study, participants will take by mouth (orally) Iptacopan or a placebo (sugar pill) every day for 29 months. During the entire study, doctors regularly check the overall health and eye condition of the participants.

  • REC name

    North of Scotland Research Ethics Committee 1

  • REC reference

    23/NS/0072

  • Date of REC Opinion

    1 Sep 2023

  • REC opinion

    Further Information Favourable Opinion