UveitisNCT06974162
Metagenomics for Ocular Inflammation
An observational study of Uveitis and Aqueous Humor, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Uveitis, Aqueous Humor, Infection
- What is being tested?
- Metagenomic sequencing of aqueous humor and Ocular Imaging
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jun 2025to 27 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients in the UK attending Moorfields Eye Hospital, London.
Who may be able to join
- 18 years of age or older with the capacity to consent
- Standard of care has not determined a clinical diagnosis
- Active ocular inflammation with risk of visual loss
- Clinically suspected infectious or para-infectious cause of ocular inflammation
Who cannot join
- Contraindication to ocular fluid sampling
- Where an urgent result within 5 days is clinically required
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Research Administration at Moorfields Eye Hospital R&D contact
United Kingdom1 site, 1 recruiting
- Recruiting
Moorfields Eye Hospital NHS Foundation Trust
London
Aishah Hassan, 02072533411, aishah.hassan2@nhs.net
About this study
Official title: Metagenomic Sequencing of Ocular Fluids in Patients With Ocular Inflammation
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.
- Conditions
- Uveitis, Aqueous Humor, Infection
- Being tested
- Metagenomic sequencing of aqueous humor, Ocular Imaging
- Keywords
- Metagenomics, Uveitis, Aqueous Humor, Ophthalmology
- Medical subject headings
- Uveitis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metagenomic sequencing of aqueous humorDiagnostic test
Metagenomic Sequencing on aqueous humor surplus to diagnostic requirements
Ocular ImagingDiagnostic test
Ocular imaging with anterior segment OCT, laser flare photometry, confocal microscopy and colour fundus photography.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ocular inflammation presumed to be infectious or para-infectious | Patients with Ocular Inflammation undergoing Metagenomics on Aqueous Humour Receives: Diagnostic Test: Metagenomic sequencing of aqueous humor; Diagnostic Test: Ocular Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of participants who receive a clinically viable result from metagenomic sequencing
Measured: 12 months
Secondary outcomes (1)
The number of patients who receive a result that leads to a change in treatment and beneficial outcome from metagenomic sequencing
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start12 Jun 2025
- Primary completion27 Nov 2026 (estimated)
- Study completion27 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974162
- Sponsor's protocol ID
- CHUC1004
- Other IDs
- 25/WM/0072, 354543
- Status last verified
- Jul 2026
- First submitted
- 7 May 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant demographics and research findings will be shared in the peer-reviewed scientific publication.
Publications
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.
PubMed 37809666Penner 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.
PubMed 37557958Doan 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.
PubMed 28526549
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metagenomic Sequencing of Ocular Fluids in Patients With Ocular Inflammation
- ClinicalTrials.gov ID
- NCT06974162
- Acronym / sponsor ID
- CHUC1004
- Conditions
- Uveitis, Aqueous Humor, Infection
- Keywords
- Metagenomics, Uveitis, Aqueous Humor, Ophthalmology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 27 Nov 2026 (estimated)
- Study completion
- 27 Nov 2027 (estimated)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ocular inflammation presumed to be infectious or para-infectious | – | Diagnostic Test: Metagenomic sequencing of aqueous humor, Diagnostic Test: Ocular ImagingPatients with Ocular Inflammation undergoing Metagenomics on Aqueous Humour |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in the UK attending Moorfields Eye Hospital, London.
Key inclusion criteria (4 listed)
- 18 years of age or older with the capacity to consent
- Standard of care has not determined a clinical diagnosis
- Active ocular inflammation with risk of visual loss
- Clinically suspected infectious or para-infectious cause of ocular inflammation
Key exclusion criteria (2 listed)
- Contraindication to ocular fluid sampling
- Where an urgent result within 5 days is clinically required
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metagenomic sequencing of aqueous humorMetagenomic Sequencing on aqueous humor surplus to diagnostic requirements | Diagnostic test | Patients with ocular inflammation presumed to be infectious or para-infectious |
| Ocular ImagingOcular imaging with anterior segment OCT, laser flare photometry, confocal microscopy and colour fundus photography. | Diagnostic test | Patients with ocular inflammation presumed to be infectious or para-infectious |
Primary outcome
The percentage of participants who receive a clinically viable result from metagenomic sequencing
Time frame: 12 months
1 secondary outcome
The number of patients who receive a result that leads to a change in treatment and beneficial outcome from metagenomic sequencing
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Background: PubMed 37809666Atkinson 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.
- Background: PubMed 37557958Penner 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.
- Background: PubMed 28526549Doan 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant demographics and research findings will be shared in the peer-reviewed scientific publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Research Administration at Moorfields Eye Hospital R&D contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveitis and Aqueous Humor, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Administration at Moorfields Eye Hospital R&D (+44 20 7253 2411, moorfields.crfenquiries@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of participants who receive a clinically viable result from metagenomic sequencing (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06974162, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.