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

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.

Current Status (July 2017): Information has been collected on a total of 532 participants who participated in IVAN Follow Up.  Images have been uploaded for the majority of participants and the images will be graded by the grading team at CARF, Belfast.  Our aim is to submit a manuscript publication in the first half of 2018.

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

Study coordinator: Dawn Phillips

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

 

The MONARCH Study

Wet age-related macular degeneration (neovascular AMD, nAMD) is the commonest cause of blindness in the UK. Most patients need a series of monthly injections followed by a period of regular check-up visits in case more injections are required. AMD can often flare up after a period when treatment has not been required so check-ups are usually needed for several years.

Home monitoring to detect the need for treatment could mean that patients would not need regular hospital check-ups. MONARCH is a diagnostic test-accuracy study designed to find out whether home monitoring tests can detect when neovascular AMD needs to be treated as well as the surveillance tests carried out at hospitals check-ups.

We have chosen three home monitoring tests for MONARCH: the first is a paper booklet of “reading tests”. The other two tests are software applications that run on an iPod touch.

Patients having treatment or check-ups at participating NHS hospitals will be invited to take part. They will be provided with an iPod touch and a mobile broadband device and will be asked to perform the home monitoring tests weekly at home over a period of 1 to 2 years. We will also interview some patients and their carers to find out their experiences of performing the tests.

We will perform the study in 5 different hospitals around the United Kingdom and aim to recruit 400 participants.

Current Status (Oct 2017): In set-up (Target date for first site opening March 2018)

This study is funded by National Institute of Health Research (NIHR) Health Technology Assessment Programme (HTA) (15/97/02)

 This study is kindly supported by:

  •          Visumetrics AB in collaboration with Novartis Sverige AB
  •          Vital Art and Science LLC
  •          KeepSight 

Contact information

Co-Chief Investigator: Dr Ruth Hogg

Co-Chief Investigator: Prof. Barney Reeves

Study Co-Ordinator: Liz Ward

Sponsor: The Queen’s University Belfast

E-mail:  MONARCH-study@bristol.ac.uk

 

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

Sponsor: University Hopsital Southampton NHS Foundation Trust 

Status: Recruiting 

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

Study coordinator: Abby Willcox

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