Metagenomics for Ocular Inflammation

NCT ID: NCT06974162

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-12

Study Completion Date

2026-07-12

Brief Summary

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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.

Detailed Description

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Conditions

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Uveitis Aqueous Humor Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with ocular inflammation presumed to be infectious or para-infectious

Patients with Ocular Inflammation undergoing Metagenomics on Aqueous Humour

Ocular Imaging

Intervention Type DIAGNOSTIC_TEST

Ocular imaging with anterior segment OCT, laser flare photometry, confocal microscopy and colour fundus photography.

Metagenomic sequencing of aqueous humor

Intervention Type DIAGNOSTIC_TEST

Metagenomic Sequencing on aqueous humor surplus to diagnostic requirements

Interventions

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Ocular Imaging

Ocular imaging with anterior segment OCT, laser flare photometry, confocal microscopy and colour fundus photography.

Intervention Type DIAGNOSTIC_TEST

Metagenomic sequencing of aqueous humor

Metagenomic Sequencing on aqueous humor surplus to diagnostic requirements

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Great Ormond Street Hospital for Children NHS Foundation Trust

OTHER

Sponsor Role collaborator

Moorfields Eye Hospital NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Moorfields Eye Hospital NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Research Administration at Moorfields Eye Hospital R&D

Role: CONTACT

+44 20 7253 2411

Facility Contacts

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Bhavna Ramchurn

Role: primary

02072533411

References

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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.

Reference Type BACKGROUND
PMID: 37809666 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37557958 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28526549 (View on PubMed)

Related Links

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Other Identifiers

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CHUC1004

Identifier Type: -

Identifier Source: org_study_id

25/WM/0072

Identifier Type: OTHER

Identifier Source: secondary_id

354543

Identifier Type: OTHER

Identifier Source: secondary_id

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