Clinical trial NCT06974162: Metagenomics for Ocular Inflammation
Official title: Metagenomic Sequencing of Ocular Fluids in Patients With Ocular Inflammation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Uveitis
Aqueous Humor
Infection
Keywords: Metagenomics
Uveitis
Aqueous Humor
Ophthalmology
Lead sponsor: Moorfields Eye Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Great Ormond Street Hospital for Children NHS Foundation Trust
First posted: 2025-05-15
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the UK attending Moorfields Eye Hospital, London.

Brief summary: The aim of this study is to apply a diagnostic test called 'metagenomic sequencing' to identify the involvement of potential infections in patients with ocular inflammation, where this hasn't been detected by currently available standard testing. For many people with ocular inflammation, no cause is ever found for their disease. In some cases, an infection or infectious trigger is suspected, but currently available tests are inadequate. Metagenomic sequencing can identify almost every globally known infection (bacteria, virus, fungi, parasites) in a sample. Therefore, it has the potential to identify an infection that has caused or triggered ocular inflammation, and as a consequence may help to identify specific treatments. It has the potential to improve our understanding of how to diagnose and treat people with this problem. This study will allow us to test the technique that has been previously optimised for brain infections, on ocular fluids. Participants will be 18 years of age or over and have active ocular inflammation which is suspected to be due to an infection, or an autoimmune process which has been triggered by an infection, but identification of this infection has not been possible using the investigations available as part of standard NHS care. Participants will be identified by the treating clinical team as requiring a sample of fluid from inside of the eye, and some of this fluid will be sent for metagenomic sequencing alongside standard testing. This study will be conducted at Moorfields Eye Hospital, London and will last for approximately a year. Participants will undergo additional non-invasive ocular imaging on the day of their clinic visit, but will not have to attend any additional research visits.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older with the capacity to consent
2. Standard of care has not determined a clinical diagnosis
3. Active ocular inflammation with risk of visual loss
4. Clinically suspected infectious or para-infectious cause of ocular inflammation

Exclusion Criteria:

1. Contraindication to ocular fluid sampling
2. Where an urgent result within 5 days is clinically required

Primary outcomes:
measure: The percentage of participants who receive a clinically viable result from metagenomic sequencing
timeFrame: 12 months
Secondary outcomes:
measure: The number of patients who receive a result that leads to a change in treatment and beneficial outcome from metagenomic sequencing
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Atkinson L, Lee JC, Lennon A, Shah D, Storey N, Morfopoulou S, Harris KA, Breuer J, Brown JR. Untargeted metagenomics protocol for the diagnosis of infection from CSF and tissue from sterile sites. Heliyon. 2023 Sep 9;9(9):e19854. doi: 10.1016/j.heliyon.2023.e19854. eCollection 2023 Sep.
citation: Penner J, Hassell J, Brown JR, Mankad K, Storey N, Atkinson L, Ranganathan N, Lennon A, Lee JCD, Champsas D, Kopec A, Shah D, Venturini C, Dixon G, De S, Hatcher J, Harris K, Aquilina K, Kusters MA, Moshal K, Shingadia D, Worth AJJ, Lucchini G, Merve A, Jacques TS, Bamford A, Kaliakatsos M, Breuer J, Morfopoulou S. Translating metagenomics into clinical practice for complex paediatric neurological presentations. J Infect. 2023 Nov;87(5):451-458. doi: 10.1016/j.jinf.2023.08.002. Epub 2023 Aug 7. No abstract available.
citation: Doan T, Acharya NR, Pinsky BA, Sahoo MK, Chow ED, Banaei N, Budvytiene I, Cevallos V, Zhong L, Zhou Z, Lietman TM, DeRisi JL. Metagenomic DNA Sequencing for the Diagnosis of Intraocular Infections. Ophthalmology. 2017 Aug;124(8):1247-1248. doi: 10.1016/j.ophtha.2017.03.045. Epub 2017 May 16. No abstract available.