MR42410 - PDS with Ranibizumab vs Aflibercept

  • Research type

    Research Study

  • Full title

    A PHASE IIIB, MULTICENTER, RANDOMIZED,VISUAL ASSESSOR-MASKED STUDY OF THEEFFECTIVENESS AND SAFETY OF A 36-WEEKREFILL REGIMEN FOR THE PORT DELIVERYSYSTEM WITH RANIBIZUMAB VS AFLIBERCEPTTREAT & EXTEND IN SUBJECTS WITHNEOVASCULAR AGE-RELATED MACULARDEGENERATION (DIAGRID)

  • IRAS ID

    1004778

  • Contact name

    Micaela Rocco

  • Contact email

    welwyn.uk_ethics@roche.com

  • Sponsor organisation

    F. Hoffman-La Roche Ltd

  • Eudract number

    2021-003226-71

  • Clinicaltrials.gov Identifier

    NCT05126966

  • Research summary

    Neovascular age-related macular degeneration (nAMD) is a form of advanced AMD that causes rapid and severe visual loss, and remains a leading cause of visual impairment in the elderly. In the next 30 years, the global population aged 60 years and older is projected to increase dramatically, resulting in a significant increase in the prevalence of nAMD from 23 million in 2010 to 80 million by 2050.

    nAMD accounted for the majority of cases of severe vision loss from AMD prior to the development of anti-vascular endothelial growth factor (anti-VEGF) therapy. Treatment of nAMD was significantly impacted by the introduction of anti- VEGF therapy, however a key challenge with this treatment is the requirement for frequent and long-term administration. Frequent intravitreal injection therapy for nAMD in clinical practice can be a substantial burden on individuals with nAMD, caregivers, and the health care system.

    Ranibizumab is a recombinant, humanised, monoclonal antibody that binds to and inhibits the biologic activity of VEGF-A and is administered by intravitreal administration.

    The PDS (Port Delivery System) is an innovative, investigational, intraocular drug delivery system that allows clinicians to use (a customised formulation of) ranibizumab with a continuous drug delivery profile.

    This study will evaluate the effectiveness and safety of a 36-week refill regimen for the PDS with ranibizumab 100 mg/mL (PDS Q36W) compared with intravitreal injections of aflibercept (2 mg) administered per a treat-and-extend regimen (aflibercept T&E) in subjects with neovascular (wet) age-related macular degeneration (nAMD).

    The study will last approx. 90 weeks for each individual patient. There will be approximately 32 patients recruited at 9 UK sites.
    The study is sponsored by F. Hoffman La Roche
    Research Summary; Version 1.0 dated 24-Feb-2022

  • REC name

    Yorkshire & The Humber - Sheffield Research Ethics Committee

  • REC reference

    22/YH/0131

  • Date of REC Opinion

    27 Jul 2022

  • REC opinion

    Further Information Favourable Opinion