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A phase II clinical trial of DARC

  • Research type

    Research Study

  • Full title

    A phase II, open label, non-randomised, single centre, clinical trial of ANX776 in Healthy Volunteers and patients with Glaucoma, Age-Related Macular Degeneration, Optic Neuritis and Down's Syndrome

  • IRAS ID

    208204

  • Contact name

    Francesca Cordeiro

  • Contact email

    m.cordeiro@ucl.ac.uk

  • Sponsor organisation

    UCL Comprehensive Clinical Trials Unit

  • Eudract number

    2016-002531-15

  • Duration of Study in the UK

    0 years, 5 months, 1 days

  • Research summary

    Apoptosis refers to the process of death of retinal cells, which play a vital role of carrying the light signal to the brain and thus facilitating vision. The DARC Technology (Detection of Apoptosing Retinal Cells) is a novel technique that utilises the unique optical properties of the eye to allow direct visualisation of nerve cells dying through apoptosis. DARC uses intravenously-delivered fluorescently-labelled Annexin V (ANX776) as the marker of retinal cell apoptosis.

    Our objective is to evaluate the efficacy of DARC, in visualising apoptotic retinal cells in patients with Glaucoma, Age-related Macular Degeneration (AMD), Optic Neuritis (ON), Down's Syndrome and in Healthy Volunteers.

    The Phase I trial of DARC has recently successfully established the safety and tolerability of ANX776, showing that it is well tolerated with only minor adverse events; this trial will therefore evaluate the extent to which we can see apoptotic cells in the aforementioned groups as well as further assess the safety and tolerability of ANX776.

    The study will be conducted within the same site which completed the Phase I trial, namely the Western Eye Hospital which has a 24/7 A&E department and a fully equipped Clinical Trials Unit.

    During 1-2 visits to the hospital (Study Visits) participants will first undergo qualification assessments to confirm eligibility and those that qualify will proceed to having a single intravenous injection of ANX776, followed by non-invasive electronic imaging of the retina and evaluation of any adverse events. In a subset of patients, non-invasive NIR signal detection will be assessed also in the brain. Participants will be free to go home within 5 hours of the intravenous injection.

    The study concludes with a 30 day post injection safety telephone call to assess any symptoms or adverse events.

  • REC name

    London - Harrow Research Ethics Committee

  • REC reference

    16/LO/1700

  • Date of REC Opinion

    14 Nov 2016

  • REC opinion

    Further Information Favourable Opinion