Current Studies

No.

Study

Status

Patient Cohort

Intervention  

Funder

Location

Chief Investigator(s)

1.

 

Starts 4/21

 

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.

COVID HARMS

Open

Uveitis patients during COVID 19 pandemic

Nil

N/A

Bristol

Tomas Burke

7.

UK Uveitis Registry

In development

Non Infectious Uveitis

Iluvien and biologic therapies vs immunomodulatory therapies

 

 

Liverpool 

Nicholas Beare

 

Completed Studies

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

 

 

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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

  1. https://www.bristol.ac.uk/news/2020/may/astute-trial.html
  2. https://dev.fundingawards.nihr.ac.uk/award/16/24/09
  3. ISRCTN31474800 https://doi.org/10.1186/ISRCTN31474800
  4. http://www.isrctn.com/ISRCTN31474800
  5. 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

  1. What is the relative efficacy and safety of adalimumab in different autoimmune uveitis diseases in the real-world clinical setting?
  2. 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