Clinical efficacy and mechanistic evaluation of Eplerenone for central serous chorio-retinopathy – the VICI randomised trial
Sponsor: University Hopsital Southampton NHS Foundation Trust
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.
Recruitment ended on 28th February 2018 and patients were followed up for 12 months. Last patient, last visit was on 28th February 2019. The results have been analysed and have been accepted for publication in the Lancet journal.
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.
The results of the VICI Trial are published in The Lancet journal.
The NIHR have also published a Signal.
You can see a snapshot of the trial in this animated video, enjoy!
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 firstname.lastname@example.org.
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.