An interventional study of care strategy in Non-infectious Uveitis, sponsored by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-03.
Sponsored by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts · Not applicable, Interventional, and Diagnostic
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.
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:
Control patients:
299 studies on the registry are indexed under Uveitis; 32 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 30 across 175 interventional studies indexed under Uveitis.
Browse Uveitis studies →Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts is the lead sponsor of 28 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
UVEITIS Patients:
Inflammatory activity requiring treatment with either one or more of the followings:
Control patients:
Exclusion Criteria:
Uveitis Patients:
Inactive disease defined as:
Control patients:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Diagnostic Test: care strategy
scheduled for cataract or vitreoretinal surgery
Diagnostic Test: care strategy
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.
Imaging database development
To develop an imaging database of Non-Infectious Uveitis of the posterior segment (NIUPS) using multimodal imaging
Time frame: 60 months
Biological constitution
To Constitute a biological collection of ocular and blood samples of NIUPS patients and controls
Time frame: 60 months
medico economic costs estimation
To estimate the current costs of treatment by ensuring linkage of cohort patients to the national claims database
Time frame: 60 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2023; primary completion for Aug 2028, 59 months later.
Of 16 interventional studies with no phase under Uveitis, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 49. This study's planned 59 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts