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DARC Phase I Clinical Trial for Early Diagnosis of Neurodegeneration

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

This study is ongoing, recruiting participants finished, final analysis in process.

Sponsor: University College, London

Collaborator: Wellcome Trust

  • Purpose

Glaucoma is a major cause of irreversible blindness worldwide, caused by retinal ganglion cell (RGC) death. This is currently identified only after significant vision loss has already occurred. RGC apoptosis is an early event in this process and therefore a potential marker for the disease prior to vision loss.

This study aims to investigate the tolerability and safety of ANX776, as part of the new Detection of Apoptosing Retinal Cells (DARC) technique. A secondary aim is to initially establish the ability of DARC to identify RGC apoptosis and diagnose glaucoma in healthy and progressive glaucoma/glaucoma-suspect/ocular hypertensive patients. As a positive control for this secondary aim of this study, patients with Non-arteritic Anterior Ischaemic Optic Neuropathy (NAION) will be recruited.

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 potentially powerful new clinical tool with which to identify patients with early glaucoma before their vision is lost. If successful, it opens the door to directly observing effects of glaucoma treatments, including the assessment of new, breakthrough therapies.