A Phase I Clinical Trial of DARC

• Research type

  Research Study

• Full title

  A Phase I, Storer Design, open-label, cross-sectional, single site trial of ANX776 in healthy volunteers, progressive glaucoma/glaucoma-suspect/ocular hypertensive subjects and non-arteritic anterior ischaemic optic neuropathy subjects.

• IRAS ID

  168041

• Contact name

  Susan Tebbs

• Contact email

  susan.tebbs@ucl.c.uk

• Eudract number

  2014-002504-25

• Duration of Study in the UK

  0 years, 4 months, 16 days

• Research summary

  Glaucoma is a major cause of irreversible blindness worldwide, caused by retinal nerve cell (retinal ganglion cells (RGC)) death. This is currently identified late after significant vision loss has already occurred. An early event in this process is RGC “apoptosis” - a particular form of cell death. This study investigates DARC (Detection of Apoptosing Retinal Cells), which uses ANX776 to identify RGC apoptosis.

  The primary objective is to evaluate the dose response in terms of tolerability and safety of ANX776 in the diagnosis of glaucoma in healthy and progressive glaucoma/glaucomasuspect/ ocular hypertensive patients, with non-arteritic anterior ischaemic optic neuropathy (NAION) patients serving as positive controls.

  Since this will be a first-in-human study, subjects below the age of 18, patients with uncontrolled systemic or eye diseases, pregnant or potential childbearing women will be excluded, as will those patients with antiphospholipid syndrome.
  Attention to patient safety has been taken into account: the study will be conducted within a public NHS hospital: the Western Eye Hospital, which has a 24/7 A&E department and where experienced clinicians will conduct the study.
  Each patient who agrees to participate in the study will receive a single intravenous injection of Anx776, followed by 6 hours of clinical monitoring and is expected to undergo 3 visits over a period of 6-8 weeks

  During the study, each patient will undergo several ophthalmological examinations, imaging of the back of the eye using established clinical devices, and blood sampling for studying the safety and toxicology profile of Anx776.

  The understanding of the safety profile of ANX776 is crucial for the use of DARC in patients, and its application as a powerful new clinical tool with which to identify patients with early glaucoma before they lose vision. It opens the door to directly observing effects of glaucoma treatments, including the assessment of new, breakthrough therapies.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  15/LO/0087

• Date of REC Opinion

  4 Feb 2015

• REC opinion

  Favourable Opinion