UveitisFAIL-UVEITISNCT06821971
Study of Risk Factors for Therapeutic Failure in Chronic Non-Infectious Uveitis After First-Line Immunosuppressive Therapy
An observational study of Uveitis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Uveitis is an inflammatory disease of the uvea, constituting the 4th leading cause of legal blindness worldwide and the 3rd leading cause of avoidable blindness . It is not a rare condition, with an incidence of 17 to 52 per 100,000 population and a prevalence of 38 to 204 per 100,000 population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2025to Aug 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective cohort study based on medical records of patients who received first-line immunosuppressive (IS) therapy for their uveitis. Patients with chronic non-infectious uveitis at Amiens-Picardie University Hospital, over the period from January 2013 to January 2023.
Who may be able to join
- Age : > 18 years old
- Uveitis requiring immunosuppressive therapy.
- Including at least one posterior involvement according to the SUN terminology: posterior, or intermediate and posterior, or anterior and posterior, or panuveitis.
Who cannot join
- Uveitis associated with multiple sclerosis or systemic lupus erythematosus.
- Ocular involvement in Behcet's disease requiring biologic therapy as first-line immunosuppressive treatment.
- Uveitis without posterior segment involvement.
- Infectious uveitis.
- Patients objecting to the use of their personal data for research purposes.
Trial locations and contacts
1 site in 1 country.
About this study
Uveitis is an inflammatory disease of the uvea, constituting the 4th leading cause of legal blindness worldwide and the 3rd leading cause of avoidable blindness . It is not a rare condition, with an incidence of 17 to 52 per 100,000 population and a prevalence of 38 to 204 per 100,000 population. In the case of cortico-dependence, it is generally accepted to propose sparing with a conventional immunosuppressant, whose efficacy is estimated at around 70%, compared with biotherapies, which are considered more effective (over 90%) but only available as 2nd-line treatment. However, there are few studies on the failure factors of this first-line treatment, such as macular thickness , gender, or vitamin D deficiency. Risk factors for flare-ups are nevertheless known, notably ethnicity, and smoking. The aim of this study is to identify risk factors for treatment failure after three months of first-line immunosuppressive therapy in patients with chronic non-infectious uveitis at Amiens-Picardie University Hospital.
- Conditions
- Uveitis
- Keywords
- Uveitis
- Medical subject headings
- Uveitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of therapeutic failure at 4 months
Therapeutic failure at 4 months following the initiation of a first-line immunosuppressant in patients with chronic non-infectious uveitis (CNIU).
Measured: 4 months
Secondary outcomes (1)
Number of therapeutic failure at 9 months
Therapeutic failure at 9 months following the initiation of a first-line immunosuppressant in patients with chronic non-infectious uveitis (CNIU).
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start14 Jan 2025
- Primary completion1 Mar 2025
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821971
- Sponsor's protocol ID
- PI2025_843_0012
- Acronym
- FAIL-UVEITIS
- Status last verified
- Jan 2025
- First submitted
- 28 Jan 2025
- Last updated
- 19 Mar 2025
- 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Risk Factors for Therapeutic Failure in Chronic Non-Infectious Uveitis After First-Line Immunosuppressive Therapy
- ClinicalTrials.gov ID
- NCT06821971
- Acronym / sponsor ID
- FAIL-UVEITIS / PI2025_843_0012
- Conditions
- Uveitis
- Keywords
- Uveitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- Aug 2025 (estimated)
- First posted
- 12 Feb 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.
Uveitis is an inflammatory disease of the uvea, constituting the 4th leading cause of legal blindness worldwide and the 3rd leading cause of avoidable blindness . It is not a rare condition, with an incidence of 17 to 52 per 100,000 population and a prevalence of 38 to 204 per 100,000 population. In the case of cortico-dependence, it is generally accepted to propose sparing with a conventional immunosuppressant, whose efficacy is estimated at around 70%, compared with biotherapies, which are considered more effective (over 90%) but only available as 2nd-line treatment. However, there are few studies on the failure factors of this first-line treatment, such as macular thickness , gender, or vitamin D deficiency. Risk factors for flare-ups are nevertheless known, notably ethnicity, and smoking. The aim of this study is to identify risk factors for treatment failure after three months of first-line immunosuppressive therapy in patients with chronic non-infectious uveitis at Amiens-Picardie University Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective cohort study based on medical records of patients who received first-line immunosuppressive (IS) therapy for their uveitis. Patients with chronic non-infectious uveitis at Amiens-Picardie University Hospital, over the period from January 2013 to January 2023.
Key inclusion criteria (3 listed)
- Age : > 18 years old
- Uveitis requiring immunosuppressive therapy.
- Including at least one posterior involvement according to the SUN terminology: posterior, or intermediate and posterior, or anterior and posterior, or panuveitis.
Key exclusion criteria (5 listed)
- Uveitis associated with multiple sclerosis or systemic lupus erythematosus.
- Ocular involvement in Behcet's disease requiring biologic therapy as first-line immunosuppressive treatment.
- Uveitis without posterior segment involvement.
- Infectious uveitis.
- Patients objecting to the use of their personal data for research purposes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of therapeutic failure at 4 months
Time frame: 4 months
Therapeutic failure at 4 months following the initiation of a first-line immunosuppressant in patients with chronic non-infectious uveitis (CNIU).
1 secondary outcome
Number of therapeutic failure at 9 months
Time frame: 9 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 19 Mar 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2025. 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 France. 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?
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?
Number of therapeutic failure at 4 months (time frame: 4 months). 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 19 Mar 2025.