Clinical Trials and Studies - Uveitis Study Group

Current Studies

No.	Study	Status	Patient Cohort	Intervention	Funder	Location	Chief Investigator(s)
1.		Open	Non infectious Uveitis	Adalimumab vs Placebo	NIHR	Oxford Bristol	Srilakshmi Sharma Andrew Dick
3.	CUP Collaboration	Open	Uveitis and Glaucoma / Ocular hypertension	Nil	N/A	Oxford BMEC	Srilakshmi Sharma
4.	NIHR Bioresource Birdshot Chorioretinopathy Study	Open	Birdshot Chorioretinopathy Uveitis	Nil	NIHR	QE Birmingham	Alastair Denniston Richard Lee
5.	Birdshot ABC	Open	Birdshot Chorioretinopathy Uveitis		NIHR, Birdshot Uveitis Society	QE Birmingham
6.	UK Uveitis Registry	In development	Non Infectious Uveitis	Iluvien and biologic therapies vs immunomodulatory therapies		Liverpool	Nicholas Beare

Completed Studies and Results

Sr. No	Study	Status	Patient Cohort	Intervention	Funder	Location	Chief Investigator	Publication Status	Links to summary
1.	OSTRICH	Completed	Steroid Use for Uveitis use in UK	None	None	Oxford	Sri Sharma	Published	Click here to read article
2.	COVID HARMS	Completed	Uveitis patients during COVID 19 pandemic	Nil	N/A	Bristol	Tomas Burke		Click here to read the article

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ASTUTE TRIAL

TITLE	Adalimumab vs placebo as add-on to Standard Therapy for autoimmune Uveitis: Tolerability, Effectiveness and cost-effectiveness: a randomized controlled , pragmatic trial
PLAIN ENGLISH SUMMARY	Adalimumab is a drug that targets chemicals released by inflamed tissue, neutralising their damage to the eye. This study aims, first, to identify patients who are most likely to benefit from adalimumab and aims to widen the group of patients eligible than is currently allowed. It will also find out the minimum dose of steroids needed by patients and study the impact of uveitis on work and medication side effects. The study aims to match the usual number of clinical visits.
FUNDERS	National Institute of Health Research
TRIALS UNIT	Bristol Clinical Trials Unit
STUDY PARTICIPANTS	Aged 18 years or over Sight-threatening Non-infectious Uveitis and greater than 5 mg/day steroid
AIMS	To assess if Adalimumab reduces treatment failures in patients with non-infectious uveitis after weaning of corticosteroids to less than or equal to 5 mg/day in a treatment run-in period.
DESIGN	Double-blind parallel multi-centre randomized placebo-controlled trial with open-label treatment run-in period. All participants start on open-label adalimumab for 16 weeks. Participants who respond to adalimumab are randomised to adalimumab or placebo for up to 128 weeks.
OUTCOME MEASURES	Time to the first treatment failure (TF) assessed at each visit after randomisation (12 weeks, 24 weeks, 36 weeks, 48 weeks, 64 weeks, 80 weeks, 96 weeks, 112 weeks, and 128 weeks)
EXPECTED DATE OF COMPLETION	APRIL 2024
MORE INFO	https://www.bristol.ac.uk/news/2020/may/astute-trial.html https://dev.fundingawards.nihr.ac.uk/award/16/24/09 ISRCTN31474800 https://doi.org/10.1186/ISRCTN31474800 http://www.isrctn.com/ISRCTN31474800 https://njl-admin.nihr.ac.uk/document/download/2032258
SOCIAL MEDIA LINKS	https://twitter.com/astutetrial

OSTRICH

TITLE	Systemic Corticosteroid Use in UK Uveitis Practice: Results from the Ocular Inflammation Steroid Toxicity Risk (OSTRICH) Study
PLAIN ENGLISH SUMMARY	Steroids are the mainstay of treatment for ocular inflammation. Long-term use of high dose steroids can cause multiple side-effects such as osteoporosis, stomach ulcers, diabetes and increase the risk of heart disease. The study compared steroid prescribing in 11 uveitis clinics around the country.
FUNDERS	N/A
Trials Unit	OXFORD
Study Participants	Uveitis consultants in Bristol, Birmingham, Cambridge, Leeds, Leicester, Liverpool, Nottingham, Oxford, Sheffield and Suffolk.
Aims	Ascertain adherence to a target of ≤7.5 mg /day of prednisolone and up to 1 course of high dose steroids per year Determine whether excess steroid prescribing is avoidable
Design	Cross-sectional observational study of steroid prescribing practice across 11 UK sites Scoring matrix applied to case notes from a sample of 5 centres to determine whether excess CS prescribing is avoidable
Recruitment status/ Date of Completion	Data collection completed in March 2019
Results	285 of 667 eligible patients (42.7%) were treated with corticosteroids in the 12-month study period. 33.7 % of those on CS (96 patients) were treated with excess CS*
Phase 2 Results	25% of excess steroid use is avoidable. The most common reason is lack of evidence of consideration of alternative strategies. No evidence for undertreatment with IMT – significantly more patients on excess CS received IMT than those below excess. No difference in doses of IMT between groups.
Conclusions and value to patients	Steroids are over-prescribed in a third of patients (33.7%) and the authors also show that there may be opportunity to reduce excess CS prescribing in a quarter of cases. Uveitis remains an area of unmet medical need, where CS may be over-utilised as a means of reducing the risk of sight loss in the absence of a sufficient range of effective therapies.
Publication Link	Read the Published study here

*Excess CS defined as follows:

Maintenance >7.5 mg /day prednisolone for > 3 consecutive months
> 1 course of > 40 mg oral steroid or >500 mg IV Methyl Prednisolone in the last year

COVID HARMS STUDY

TITLE	COVID HARMS
PLAIN ENGLISH SUMMARY	The COVID 19 pandemic has disrupted routine healthcare , particularly , during the early phase of the pandemic. This study aims to understand whether patients with uveitis across in the U.K experienced adverse healthcare outcomes as a consequence of the pandemic.
FUNDERS	N/A
TRIALS UNIT	Bristol
STUDY PARTICIPANTS	Uveitis centres in the UK
AIMS	To assess if patients with Uveitis come to systemic and / or ocular harm due to COVID 19 pandemic
Design	Observational , cross-sectional study
Outcome Measures	Collating data regarding Uveitis patients who may have come to ocular/systemic harm due to any factors related to the COVID-19 pandemic. Classifying COVID related Harms as Catastrophic, Major, Moderate, Minor
Recruitment status/ DATE OF COMPLETION	For additional information, queries and/or for copies of the service evaluation registration/DPIA forms please contact sonja.smith@nnuh.nhs.uk or tomasburke@nhs.net. Click for Survey
Links	Click here for more information

CUP Collaboration

TITLE	CUP : GlauComa in Uveitis with high Pressure
PLAIN ENGLISH SUMMARY	30% of blindness in uveitis is caused by glaucoma. This is caused by high pressure in the eye due to steroid drops or the effect of inflammation on the parts of the eye which keep pressure at a normal level. CUP is a collaboration between uveitis and glaucoma specialists to understand the variation in the way we treat high pressure and glaucoma in the eye. The CUP collaborators will conduct several studies to address our study aims. This information will lead to setting standards for care of uveitis patients with high pressure and studying the impact of these on patient care.
FUNDERS	N/A
TRIALS UNIT	Oxford and BMEC
STUDY PARTICIPANTS	Nationwide Glaucoma and Uveitis Specialists
Aims	Identify variations in care nationally within glaucoma and uveitis specialists Literature review of existing recommendations for practice Identify causes of glaucoma progression in uveitis patients Agree national glaucoma care pathways through a Delphi consensus process Prospective study of outcomes for patients
Study Design	Cross sectional studies of adherence to NICE guidelines in uveitis patients with high pressure/ glaucoma Retrospective cohort study causes of glaucoma progression in uveitis Systematic review Surveys of clinician practice Delphi Consensus Process Prospective cohort study of combined glaucoma -uveitis clinics*
Recruitment status/ estimated date of Completion	Recruiting. Completion 12/21 ( * in development)
Links	Contribute your views by completing this 15 minute survey

UK Uveitis Registry

TITLE	UK Uveitis Registry
PLAIN ENGLISH SUMMARY	Uveitis is a potentially sight threatening condition with a long term impact on quality of life . With the advent of newer Biologics and immunomodulatory drugs, this complex condition can be managed better than ever before. This observational study aims to create a UK wide database of Non Infectious Uveitis patients , and compare treatment outcomes as well as safety profiles for these newer drugs/implants .
FUNDERS	Under consideration
TRIALS UNIT	Liverpool, Birmingham , London , Manchester
STUDY PARTICIPANTS	Patients with Non Infectious Uveitis in a Hospital Setting , ophthalmology clinics and inpatients.
Aims	Primary Aims Determine the relative efficacy and safety of adalimumab in different autoimmune uveitis diseases Compare the efficacy and safety of long-acting intraocular steroid implant to systemic immunosuppression in uveitis. Secondary Aims Determine the safety of anti-TNF agents when used for specifically ocular conditions. Establish treatment outcomes in uveitis including quality of life data. Compare quality of life outcomes between patients treated with systemic immunosuppression, adalimumab and long-acting local therapy. Establish research registry for uveitis.
Study Design	Observational study using web based data entry software
Research Questions	What is the relative efficacy and safety of adalimumab in different autoimmune uveitis diseases in the real-world clinical setting? How does the efficacy and safety of long-acting intraocular steroid implant compare to systemic immunosuppression in uveitis in the real-world clinical setting?
Recruitment status/ estimated date of Completion	5 years
Links	Watch this space for more updates

Birdshot Chorioretinopathy Studies

TITLE	BCR. Birdshot Chorioretinopathy NIHR BioResource – Rare Diseases study project
PLAIN ENGLISH SUMMARY	Birdshot Chorioretinopathy (BCR) is a rare autoimmune condition which is strongly associated with the class I MHC molecule, HLA-A29. The ocular phenotype is of a bilateral posterior uveitis which is seen as a characteristic pattern of chorioretinal lesions (pale yellow flecks or ‘birdshot spots'), which may be associated with other signs of mild intraocular inflammation. No clear systemic phenotype has yet been identified. BCR can cause insidious but significant sight loss, and most patients require life-long immunosuppression to try to stabilise the condition. Due to its distinctive phenotype, BCR potentially provides one of the purest cohorts for experimental studies, in which BCR may be an archetype for the wider group of uveitis syndromes.
FUNDERS	NIHR
TRIALS UNIT	Moorfields
STUDY PARTICIPANTS	Inclusion Patients with a clinical diagnosis of BCR based on the Levinson et al Research Criteria for the Diagnosis of BCR: Results of an International Consensus Conference will be included. Required characteristics therefore include: bilateral disease, presence of at least three peripapillary “birdshot lesions” inferior or nasal to the optic disk in at least one eye, with only low grade inflammation elsewhere (no more than 1+ cells in the anterior chamber and no more than 2+ vitreous haze). Retinal vasculitis or cystoid macular oedema are considered supportive but are not essential. Exclusion Patients with evidence suggestive of forms of uveitis other than BCR. Specifically the following would lead to exclusion: keratic precipitates, posterior synechiae, or the presence of infectious, neoplastic, or other inflammatory diseases that can cause multifocal choroidal lesions.
Aims	The Bioresource aims to collect cohorts of patients with BCR for recall to natural history studies, drug trials, and cellular investigations.
Study Design	NIHR Bioresource Cohort
Recruitment status/ estimated date of Completion	Open for Recruitment
Links	Click here for more information