Glaucoma Clinical Trial
Official 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
Glaucoma is a major cause of irreversible blindness worldwide, caused by retinal nerve cell
(RGC) death. This is currently identified only after significant vision loss has already
occurred with an early event in, and a potential marker of, this process being RGC
"apoptosis" (a form of cell death).
This study aims to investigate the tolerability and safety of ANX776, as part of the new
Detection of Apoptosing Retinal Cells (DARC) technique. This has been developed by the
laboratory of DARC IP holder and grant applicant: Prof. M. Francesca Cordeiro. A secondary
aim is to initially establish the ability of DARC to identify RGC apoptosis in the diagnosis
of 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.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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