NCT02394613

A Phase I Clinical Trial of DARC

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Glaucoma
• Ocular Hypertension
• Glaucoma, Suspect

Interventions

Type	Name	Description
DRUG	ANX776	Single intravenous injection

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-11-01
• Completion: 2016-08-01
• First posted: 2015-03-20
• Last updated: 2016-05-26

Locations

1 site across 1 country: United Kingdom