A Phase I Clinical Trial of DARC

Phase 1

• Conditions: Ocular Hypertension; Glaucoma, Suspect; Glaucoma
• Interventions: Drug: ANX776

• Registration Number: NCT02394613
• Lead Sponsor: University College, London

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-19
• Study First Posted: 2015-03-20
• Study Start: 2015-05
• Status Verified: 2015-08
• Primary Completion: 2015-11
• Last Update Submitted: 2016-05-25
• Last Update Posted: 2016-05-26
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ANX776	ANX776	Using and increasing dose storer design, GLAUCOMA and NORMAL patients will be randomly grouped to received the intervention (0.1 mg, 0.2 mg, 0.4 mg, 0.5 mg). 1 NAION patient will receive each dose once it has been proven safe in GLAUCOMA and NORMAL patients, as part of the secondary objective of this trial.

Primary Outcome Measures

Name	Time	Method
Safety of ANX776 as defined by the number and nature of adverse events	24 hours	Serious and adverse medical events will be recorded

Secondary Outcome Measures

Name	Time	Method
DARC Count	6 hours	Confocal Laser-Scanning Ophthalmoscopy (cSLO) imaging will be used to ascertain the number of apoptosing retinal cells in each of the study populations.

Trial Locations

Locations (1)

Western Eye Hospital, Imperial College Healthcare NHS Trust,; 🇬🇧 London, United Kingdom