Adalimumab vs placebo as add-on to Standard Therapy for autoimmune Uveitis: Tolerability, Effectiveness and cost-effectiveness: a randomized controlled trial.

Status: In set-up

Sponsor: University Hospitals Bristol NHS Foundation Trust

Autoimmune uveitis (“uveitis”) is a term for several rare eye diseases in which the body’s own immune system causes sight-threatening damage to the light sensitive retina at the back of the eye. Uveitis causes sight loss from inflammation inside the eye, damage to blood vessels in the retina or leakage of fluid into the central, most sensitive area of the retina. Two in 10,000 people are at risk of serious sight loss from uveitis. Usual treatment for autoimmune uveitis involves low dose steroids and one or two other drugs to reduce inflammation. Unfortunately, many patients do not respond to or tolerate usual treatment, or they need high dose steroids to control the uveitis. Long term high dose steroids increase the risk of heart attack, stroke, and infection and affect physical and mental health.

Recent studies suggest a drug called adalimumab, which neutralises a chemical in the body called TNF-alpha, is an effective way to treat uveitis in some patients. However, drugs like adalimumab can have serious side effects and more evidence is required to identify which patients with uveitis benefit the most from adalimumab, both with respect to their vision and quality of life, including treatment side effects.

The ASTUTE Trial aims, first, to identify patients who are most likely to benefit from adalimumab. Participants will be given adalimumab for a 16-week trial period in combination with their usual medications for uveitis. Over the 16 weeks, doctors will aim to reduce the steroid dose to a low level that should not cause side effects.

Then, patients who are successfully treated with adalimumab and low dose steroids will enter the main randomised, double-masked placebo-controlled trial. Regular eye examinations, imaging and questionnaires will be used to assess how well patients are doing. This part of the study, which will treat and follow up patients for 12 to 30 months, will find out whether adalimumab is better at preventing recurrence of uveitis than the placebo and whether adalimumab is cost-effective compared to the placebo treatment.

Patients will be recruited from >20 UK NHS hospitals (400 to the 16-week trial period, of which 174 will progress into the main randomised trial).

Patients with uveitis have contributed to this study from the start, helping to: design the protocol; identify patient-reported outcome measures; co-author the lay summary; draft the funding application; provide feedback on the trial design and participating in a national survey to assess support for the study.

This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme (project reference 16/24/09). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

Contact Information

Chief investigator: Prof Andrew Dick

Trial Coordinators: Abby O’Connell & Hana Tabusa

Email: astute-trial@bristol.ac.uk

 

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

Status: Published

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.

The results can be viewed on the EU Clinical Trials register (EudraCT) by clicking this link https://www.clinicaltrialsregister.eu/ctr-search/search?query=2015-002608-97. Several manuscripts documenting the findings are being written up and will be submitted for publication imminently.

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

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

 

The MONARCH Study

Current StatusIn Follow Up

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 6 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 
  •          Genentech Inc, a member of the Roche Group
  •          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: Robin Wickens

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

Gloucester Royal Hospital - 0300 422 3853