Five year observational follow-up of the IVAN trial cohort: a study of function and morphology

IVAN Follow-Up will follow up participants in the Inhibition of VEGF in Age-related choroidal Neovascularisation (IVAN) trial to answer additional research questions of major importance to the UK National Health Service (NHS) about the management of wet age-related macular degeneration (AMD) in the longer term.

Emerging information suggests that despite continuing treatment with anti-VEGF drugs for two years or longer many patients will lose vision. It appears that anti-VEGF drugs do not prevent scarring and if used for many years may actually promote thinning of the retina. However, few studies have investigated these effects over many years of treatment.

20 of the original IVAN investigating sites have invited a total of 411 participants to a one-off research visit to have ophthalmic images taken, to obtain visual acuities (standard and low luminance) and to complete a questionnaire. IVAN Follow Up will also collect retrospective information about how well participants are seeing, whether they are still being reviewed and treated in the NHS, whether the second eye has needed treatment, and how their current level of vision affects their quality of life. All participant images will be uploaded to the CARF grading centre in Belfast. Retrospective information and images will also be collected on a further 126 participants who have died since IVAN.

This project is funded by the National Institute for Health Research Heath Technology Assessment Programme, project number 07/36/501.

Contact Information

Chief Investigator: Professor Usha Chakravarthy, Centre for Vision and Vascular Science, Queen’s University Belfast

Trial Co-ordinator: Dawn Phillips

E-mail: ivan-trial@bristol.ac.uk

 

Clinical efficacy and mechanistic evaluation of Eplerenone for central serous chorio-retinopathy – the VICI randomised trial.

Central serous chorio-retinopathy (CSCR) is a poorly understood eye disease. It affects the eye tissue which senses light (the retina). In CSCR fluid spontaneously gathers under the retina. This can lead to permanent vision loss in about a third of cases. Some cases resolve but some persist for years, recur or affect the second eye.

The cause is unknown although it can occur in families and some genetic changes have been found.

Currently there are no proven treatments for this disease, but there have been some reports of patients having a good response to treatment with a drug called eplerenone which removes the fluid under the retina.

The VICI study will look at the benefit of using eplerenone in the treatment of patients with CSCR. However we do not know for sure how effective this treatment is as it has not been tested in a large group of patients, and it is currently unlicensed for use in the treatment of CSCR.

VICI will be the first randomised, double-masked, placebo-controlled clinical trial to find out if eplerenone with usual care in CSCR is better than placebo treatment with usual care. We hope this will establish the first scientifically proven therapy for CSCR.

To include enough patients to provide an informative result we will perform the study in 20 different hospitals around the United Kingdom and aim to recruit 104 patients (52 patients randomised to each group).

Patients and NHS research support teams have helped design the study and will oversee the conduct of the study. The trial has been carefully costed by a clinical trials unit, taking into consideration NHS Treatment costs.

Contact information

Chief Investigator: Professor Andrew Lotery, Professor of Ophthalmology, University Hospital Southampton

Trial Co-Ordinator: Lucy Ellis

E-mail: vici-trial@bristol.ac.uk