Non-infectious UveitisCHRONOSNCT05928754
Prospective CoHoRt Of Non-infectious Intermediate, pOsterior or panuveitiS
A study testing care strategy in people with Non-infectious Uveitis, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts.
Trial summary
prospective, cohort, longitudinal, multicenter, non-randomized study of patients with non-infectious posterior segment uveitis or panuveitis, with a group of control patients (scheduled for cataract or vitreoretinal surgery) and constitution of biological collection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-infectious Uveitis
- What is being tested?
- care strategy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Aug 2028
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- UVEITIS Patients:
- Adult patients (≥ 18 years);
- Non-infectious uveitis;
- Intermediate, posterior or panuveitis;
- Inflammatory activity requiring treatment with either one or more of the followings:
- Systemic corticosteroids or periocular or intravitreal injections of corticosteroids;
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- Immunosuppressants: methotrexate, azathioprine, cyclosporine, etc.;
- Biotherapy: infliximab, adalimumab, tocilizumab;
- Patients with health insurance;
- Written Informed consent obtained at enrolment in the study.
- Control patients:
- Adult patients (≥ 18 years);
- Scheduled patients ( Non-urgente procedure) for cataract or vitreoretinal surgery;
- Patients with health insurance;
- Written Informed consent obtained at enrolment in the study.
Who cannot join
- Uveitis Patients:
- Isolated anterior uveitis ;
- Inactive disease defined as:
- Absence of inflammatory chorioretinal and/or inflammatory retinal vascular lesion;
- Anterior chamber cell grade< 0.5+;
- Vitreous haze grade <0.5+;
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- Pregnant or breastfeeding woman at the inclusion visit;
- Patient under legal protection (" curatelle " or " tutelle ");
- Patient denied freedom by a legal or administrative order.
- Control patients:
- Pregnant or breastfeeding woman;
- Unscheduled (urgent) cataract or vitreoretinal surgery;
- Patient under legal protection (" curatelle " or " tutelle ");
- Patient denied freedom by a legal or administrative order.
About this study
prospective, cohort, longitudinal, multicenter, non-randomized study of patients with non-infectious posterior segment uveitis or panuveitis, with a group of control patients (scheduled for cataract or vitreoretinal surgery) and constitution of biological collection.
Read the detailed description
Description of the clinical characteristics and evolution in a large cohort of patients with non-infectious uveitis, allowing to identify prognostic or predictive factors of response after treatment of these different forms of non-infectious uveitis of the posterior segment or panuveitis (factors that are currently not well known).
Uveitis patients:
- Blood sample (20ml): Additional 20 ml blood sample during the first visit and potentially during follow-up (if necessary) for the purpose of the biological collection;
- Ocular sample (aqueous humor, vitreous): if required by the clinical context for the needs of the biological collection;
- Specific imaging: adaptive optics or Doppler holography, these procedures will be indicated on a case-by-case basis, at the investigator's discretion, and concern only patients with inflammatory vascular damage (5 to 10% of patients in the uveitis cohort);
- Quality of Life NEI-VFQ 25: provided at the inclusion visit and at follow-up visits M3-V2, M12-V5 and M24-V7.
Control patients:
- Blood sample (20ml): Additional 20 ml blood sample during the inclusion visit at the time of the surgical scheduled procedure for the needs of the biological collection;
- Ocular sample (aqueous humor, vitreous): considered as surgical waste, the tissue residues will be collected during the scheduled surgical procedure for cataract or vitreoretinal surgery for the needs of the biological collection;
- Conditions
- Non-infectious Uveitis
- Being tested
- care strategy
- Keywords
- non-infectious uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
care strategyDiagnostic test
Uveitis patients:
- Blood sample (20ml): Additional 20 ml blood sample during the first visit and potentially during follow-up (if necessary) for the purpose of the biological collection;
- Ocular sample (aqueous humor, vitreous): if required by the clinical context for the needs of the biological collection;
- Specific imaging: adaptive optics or Doppler holography, these procedures will be indicated on a case-by-case basis, at the investigator's discretion, and concern only patients with inflammatory vascular damage (5 to 10% of patients in the uveitis cohort);
- Quality of Life NEI-VFQ 25: provided at the inclusion visit and at follow-up visits M3-V2, M12-V5 and M24-V7.
| Study group | Role | What they receive |
|---|---|---|
| Uveitis Patients | Experimental | Uveitis Patients: intermediate, posterior or panuveitis noninfectious uveitis with Inflammatory activity requiring treatment with either one or more of the following:
1. Systemic corticosteroids or periocular or intravitreal injections of corticosteroids
2. Immunosuppressants: methotrexate, azathioprine, ciclosporine….
3. Biotherapy: infliximab, adalimumab, tocilizumab Receives: Diagnostic Test: care strategy |
| Control Patients | Active comparator | scheduled for cataract or vitreoretinal surgery Receives: Diagnostic Test: care strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging database development
To develop an imaging database of Non-Infectious Uveitis of the posterior segment (NIUPS) using multimodal imaging
Measured: 60 months
Biological constitution
To Constitute a biological collection of ocular and blood samples of NIUPS patients and controls
Measured: 60 months
medico economic costs estimation
To estimate the current costs of treatment by ensuring linkage of cohort patients to the national claims database
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study startSep 2023 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-infectious 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928754
- Sponsor's protocol ID
- P22-01
- Acronym
- CHRONOS
- Status last verified
- Jun 2023
- First submitted
- 26 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective CoHoRt Of Non-infectious Intermediate, pOsterior or panuveitiS
- ClinicalTrials.gov ID
- NCT05928754
- Acronym / sponsor ID
- CHRONOS / P22-01
- Conditions
- Non-infectious Uveitis
- Keywords
- non-infectious uveitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsUniversity, hospital or other
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere
- Study start
- Sep 2023 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 3 Jul 2023 (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.
prospective, cohort, longitudinal, multicenter, non-randomized study of patients with non-infectious posterior segment uveitis or panuveitis, with a group of control patients (scheduled for cataract or vitreoretinal surgery) and constitution of biological collection.
Detailed description
Description of the clinical characteristics and evolution in a large cohort of patients with non-infectious uveitis, allowing to identify prognostic or predictive factors of response after treatment of these different forms of non-infectious uveitis of the posterior segment or panuveitis (factors that are currently not well known).
Uveitis patients:
- Blood sample (20ml): Additional 20 ml blood sample during the first visit and potentially during follow-up (if necessary) for the purpose of the biological collection;
- Ocular sample (aqueous humor, vitreous): if required by the clinical context for the needs of the biological collection;
- Specific imaging: adaptive optics or Doppler holography, these procedures will be indicated on a case-by-case basis, at the investigator's discretion, and concern only patients with inflammatory vascular damage (5 to 10% of patients in the uveitis cohort);
- Quality of Life NEI-VFQ 25: provided at the inclusion visit and at follow-up visits M3-V2, M12-V5 and M24-V7.
Control patients:
- Blood sample (20ml): Additional 20 ml blood sample during the inclusion visit at the time of the surgical scheduled procedure for the needs of the biological collection;
- Ocular sample (aqueous humor, vitreous): considered as surgical waste, the tissue residues will be collected during the scheduled surgical procedure for cataract or vitreoretinal surgery for the needs of the biological collection;
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uveitis Patients | Experimental | Diagnostic Test: care strategyUveitis Patients: intermediate, posterior or panuveitis noninfectious uveitis with Inflammatory activity requiring treatment with either one or more of the following: 1. Systemic corticosteroids or periocular or intravitreal injections of corticosteroids 2. Immunosuppressants: methotrexate, azathioprine, ciclosporine…. 3. Biotherapy: infliximab, adalimumab, tocilizumab |
| Control Patients | Active comparator | Diagnostic Test: care strategyscheduled for cataract or vitreoretinal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Adult patients (≥ 18 years);
- Non-infectious uveitis;
- Intermediate, posterior or panuveitis;
- Inflammatory activity requiring treatment with either one or more of the followings:
- Patients with health insurance;
Key exclusion criteria (14 listed)
- Isolated anterior uveitis ;
- Inactive disease defined as:
- Pregnant or breastfeeding woman at the inclusion visit;
- Patient under legal protection (" curatelle " or " tutelle ");
- Patient denied freedom by a legal or administrative order.
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 |
|---|---|---|
| care strategyUveitis patients: * Blood sample (20ml): Additional 20 ml blood sample during the first visit and potentially during follow-up (if necessary) for the purpose of the biological collection; * Ocular sample (aqueous humor, vitreous): if required by the clinical context for the needs of the biological collection; * Specific imaging: adaptive optics or Doppler holography, these procedures will be indicated on a case-by-case basis, at the investigator's discretion, and concern only patients with inflammatory vascular damage (5 to 10% of patients in the uveitis cohort); * Quality of Life NEI-VFQ 25: provided at the inclusion visit and at follow-up visits M3-V2, M12-V5 and M24-V7. | Diagnostic test | Control Patients, Uveitis Patients |
Primary outcome
Imaging database development
Time frame: 60 months
To develop an imaging database of Non-Infectious Uveitis of the posterior segment (NIUPS) using multimodal imaging
Biological constitution
Time frame: 60 months
To Constitute a biological collection of ocular and blood samples of NIUPS patients and controls
medico economic costs estimation
Time frame: 60 months
To estimate the current costs of treatment by ensuring linkage of cohort patients to the national claims database
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 3 Jul 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing care strategy in people with Non-infectious Uveitis, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts.
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 15 inclusion and 14 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: opening soon, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging database development (time frame: 60 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2023.