DARC II

A phase II clinical trial of ANX776 in healthy volunteers and patients with Glaucoma, Age-Related Macular Degeneration and Optic Neuritis

The Wellcome Trust has funded the DARC II trial. The study drug ANX776 consists of the protein annexin bound to a fluorescent label molecule. ANX776 works by binding to apoptosing retinal ganglion cells in the eye, allowing researchers to visualise dying cells as a bright dot using scanning laser ophthalmoscopy. This technique is called Detection of Apoptosing Retinal Cells, or 'DARC' for short.

The greatest advantages of DARC are its real time, high resolution, in-vivo imaging, and its non-invasive nature. These characteristics, together with the ability of this technology to visualise individual apoptosing cells, make it an ideal tool for the assessment of retinal neurodegenerative disease.

The DARC II trial will involve 100 participants in total, 40 healthy volunteers and 20 patients with glaucoma, age-related macular degeneration and optic neuritis. The DARC II trial involves the Intravenous injection of a single dose of ANX776 (0.4mg) followed by assessment of retinal cells apoptosis performed using diagnostic retinal imaging. The primary outcome measure is the efficacy of DARC ascertained by counting the number of apoptosing retinal cells visualised 4 hours after iv injection of 0.4mg of ANX776. Key secondary outcomes are safety and tolerability through the evaluation and grading of adverse events in all study groups.

The current gold standards for the diagnosis of glaucoma, age-related macular degeneration and optic neuritis are suboptimal. It is believed that DARC could provide an objective and earlier diagnosis for these conditions before functional visual impairment occurs. Furthermore, through monitoring of a reduction of apoptosing retinal cells, DARC could provide a system for monitoring effectiveness of potential treatments.

The DARC II clinical trial is now closed.