WR42221 - Ranibizumab with PDS in Wet AMD

  • Research type

    Research Study

  • Full title

    A PHASE IIIb, GLOBAL, MULTICENTER, RANDOMIZED, VISUAL ASSESSOR−MASKED STUDY OF THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF A 36-WEEK REFILL REGIMEN FOR THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (VELODROME)

  • IRAS ID

    294986

  • Contact name

    Head, EU/ROW Regulatory Affairs Pharmaceutical Division, PDR

  • Contact email

    global.eudract@roche.com

  • Sponsor organisation

    F Hoffmann-La Roche Ltd

  • Eudract number

    2020-001313-20

  • Clinicaltrials.gov Identifier

    NCT04657289

  • Duration of Study in the UK

    2 years, 2 months, 29 days

  • 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 23.47 million in 2010 to 80.44 million by 2050.
    Although nAMD is comparatively uncommon,it 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 injections in clinical practice can be a substantial burden on patients,caregivers and the health care system.

    Ranibizumab is a recombinant, humanized, monoclonal antibody that binds to and inhibits the biologic activity of VEGF-A that is administered by intravitreal administration.
    The PDS (Port Delivery System) is an innovative, investigational, intraocular drug delivery system that allows clinicians to use ranibizumab with a continuous drug delivery profile.

    This study will evaluate the efficacy, safety, and pharmacokinetics of ranibizumab 100mg/ml delivered via the PDS every 36 weeks(Q36W)compared with every 24 weeks(Q24W).Enrolment of approximately 442 patients globally is planned to randomise 354 patients with nAMD. All patients will have the PDS(pre-filled with ranibizumab) implanted, then at week 24 patients who have not met Disease Activity Criteria will be randomised to either Q36W refill or Q24W refill.Those who do meet the criteria will exit the study and be offered an OLE study.

    The study will last approx. 18-22 months for each individual patient.There will be approximately 40 patients recruited at 10 UK sites

    The study is sponsored by F. Hoffman La Roche
    Research Summary; Version 1.0 dated 15-Feb-2021

  • REC name

    East of England - Cambridge Central Research Ethics Committee

  • REC reference

    21/EE/0120

  • Date of REC Opinion

    22 Jun 2021

  • REC opinion

    Further Information Favourable Opinion