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: The final report was submitted to the funders (NIHR HTA) in April 2018. The archive process will begin at all the sites. Our aim is to publish several manuscripts documenting the findings.

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

Current Status: Recruiting

Sponsor: The Queen’s University Belfast

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 as part of an integrated qualitative study being carried out at select participating hospitals.

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

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 

The latest version of the newsletter can be read here 

Contact information

Co-Chief Investigator: Dr Ruth Hogg & Prof. Barney Reeves 

Study Co-Ordinator: Liz Ward

Sponsor: The Queen’s University Belfast

E-mail:  MONARCH-study@bristol.ac.uk

Participating sites include:

Royal Victoria Hospital (Belfast) – 02890 634252

James Paget University Hospital (Great Yarmouth) – 01493 453856

Moorfields Eye Hospital (London) – 02072 533411 Ext. 4451

Royal Liverpool & Broadgreen University Hospital (Liverpool) – 0151 7063986

University Hospital Southampton – 02381 204606

 

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

Sponsor: University Hopsital Southampton NHS Foundation Trust 

Status: In Follow Up

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 are performing the study in 22 different hospitals around the United Kingdom and have recruited 114 patients. Recruitment ended on 28th February 2018 . Patients will be followed up for 12 months after the end of recruitment.

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.

General Data Protection Rules (GDPR). For patients who are participating in the VICI Trial please read the statement below for information on how your data for the study is used.

Southampton University Hospital NHS Foundation Trust is the sponsor for this study based in the United Kingdom. We will be using information from you and your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. The CTEU Bristol who coordinates the study will keep identifiable information about you for 5 years after the study has finished.

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible. You can find out more about how we use your information by contacting vici-trial@bristol.ac.uk.

Your local NHS Trust will keep your name, NHS number and contact details confidential and will not pass this information to Southampton University Hospital NHS Foundation Trust. Your local NHS Trust will use this information as needed, to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Certain individuals from Southampton University Hospital NHS Foundation Trust and regulatory organisations may look at your medical and research records to check the accuracy of the research study. Southampton University Hospital NHS Foundation Trust will only receive information without any identifying information. The people who analyse the information will not be able to identify you and will not be able to find out your name, NHS number or contact details. Your local NHS Trust will keep identifiable information about you from this study for 5 years after the study has finished.

When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research. This information will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health and care research, and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.

Contact information

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

Study coordinator: Abby Willcox

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