Extract

Background and study aims The retina is the name given to the layer at the back of the eye which is sensitive to light. When light enters the eye, the cells that make up the retina convert the light rays into electrical impulses, which travel via the optic nerve into the brain so they can be interpreted as images. Apoptosis is a process of programmed cell death or “cellular suicide”. DARC Technology (Detection of Apoptosing Retinal Cells) is a new technique that uses the unique properties of the eye to make it possible to view nerve cells in the eye dying via optosis. The technique uses a substance called ANX776, which has previously been shown to be well tolerated in patients and cause minimal side effects. The aim of this study is to further evaluate the extent to which it is possible to see apoptosis in retinal cells in patients with a range of long-term eye diseases and healthy people of the same age. Who can participate? Adults with eye diseases and healthy volunteers of the same age. What does the study involve? All participants attend a single study visit at which they receive an injection of ANX776 into a vein. Following this, they undergo an eye exam in order to look at the retina. Participants are followed up with a telephone call after 30 days to find out if they have had any side effects. What are the possible benefits and risks of participating? There are unlikely to be any direct benefits involved with participating, although the information gained from this study may help to improve treatment for future patients. The main risks are discomfort during the eye examination, or discomfort caused by bright, flashing lights. One of the tests is an intra-ocular pressure measurement (which measures the pressure inside the eye). There is a very small chance of getting a scratch on the surface of the eye during this test. If this does happen, it should heal on its own. The trial involves eye numbing drops which in rare cases may cause an allergic reaction, difficulty in breathing or low blood pressure. The study drug will be injected using a cannula. Risks and side effects are bruising, swelling, infection, or bleeding. Where is the study run from? Western Eye Hospital (UK) When is the study starting and how long is it expected to run for? February 2017 to July 2017 Who is funding the study? Wellcome Trust (UK) Who is the main contact? Ms Francesca Cordeiro [email protected]

Inclusion criteria

• Specialty: Ophthalmology, Primary sub-specialty: Retina (including Diabetes); UKCRC code/ Disease: Eye/ Other disorders of eye and adnexa

Links

• isrctn