UveitisUMetAzaNCT05370690
Retrospective Comparison of the Efficacy of Methotrexate and Azathioprine as Background Treatment for Uveitis of Undetermined Origin: Single-centre Retrospective Study From 2005 to 2020
An observational study of Uveitis, run by University Hospital, Brest at 1 site in France.
Trial summary
Retrospective study at the Brest universitary hospital to evaluate the efficacy of methotrexate (MTX) and azathioprine (AZA) in background treatment of unidentified non anterior uveitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2022to 1 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with uveitis (intermediate, posterior or panuveitis) of undetermined origin diagnosed and or followed between January 2005 and March 2020 at the CHRU of Brest and who received treatment with methotrexate or azathioprine.
Who may be able to join
- Patient age>18 years
- Intermediate, posterior or panuveitis diagnosed clinically by an ophthalmologist.
- Patient treated with azathioprine or methotrexate
Who cannot join
- Patient under legal protection
- Methotrexate dose < 10mg or azathioprine < 50mg
- Systemic or ophthalmological disease (Behçet, sarcoidosis, Retinopathy of Birdshot, etc.)
- Infectious uveitis
- Ophthalmological surgery < 30 days
- Delayed corticosteroid ocular implant > 3 months
- Introduction of biotherapy simultaneously or prior to immunosuppressive treatment
Trial locations and contacts
1 site in 1 country.
Xavier SAVARY contact
France1 site
CHU de Brest
Brest, 29609
Benedicte ROUVIERE, benedicte.rouviere@chu-brest.fr
About this study
Retrospective study at the Brest universitary hospital to evaluate the efficacy of methotrexate (MTX) and azathioprine (AZA) in background treatment of unidentified non anterior uveitis.
Read the detailed description
Uveitis is a major cause of ocular damage, responsible for 5 to 10% of blindness in the world. More broadly, up to 35% of patients with uveitis have visual acuity impairment ranging from "significant" to "legal blindness" [4]. The figures of "legal blindness" up to 25% according to the studies
The objective of any anti-inflammatory therapy strategy for uveitis is to:
- Quickly control eye inflammation to minimize irreversible structural damage and maintain visual function.
- Prevent inflammatory recurrences, which cause complications and co-morbidity.
- Limit the use of systemic corticosteroids over the course of their deleterious metabolic effects.
- Optimize the risk-benefit balance and promote compliance.
The studies concerning uveitis linked with another disease are multiple and are therefore well documented. Uveitis of undetermined origin is classified, by definition, as uveitis of non-infectious origin.
Anterior uveitis are available for local treatment prior to any discussion of introducing systemic treatment. Intermediate uveitis, posterior and panuveitis justify systemic treatment.
Systemic treatments used in these uveitis are METHOTREXATE, AZATHIOPRINE, MYCOPHENOLATE MOFETIL CICLOSPORINE, INTERFERON ALPHA, anti-TNF alpha. Antimetabolites (azathioprine, mycophenolate mofetil and methotrexate) are the most commonly used immunosuppressants.
Several randomized studies (retrospective or prospective) compared the use of METHOTREXATE (MTX) and MYCOPHENOLATE MOFETIL (MMF), in the management of non-infectious inflammatory ocular disease as a corticosteroid-sparing treatment.
Although MMF has a faster response time compared to MTX for inflammation control, the success rate is equivalent. These studies found no superiority of one molecule over the other .
There are no studies in the literature comparing the use of MTX versus AZA in treatment of these non-prior uveitis of undetermined origin. These two molecules are frequently used in our center as first-line treatment of idiopathic uveitis in an undifferentiated way.
The objective of this study is therefore to determine whether one of these molecules should be preferred for the management of our patients.
- Conditions
- Uveitis
- Keywords
- Uveitis idiopatic (except anterior), azathioprine, methotrexate
- Medical subject headings
- Uveitis
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effectiveness of methotrexate versus azathioprine in controlling the inflammation of intermediate, posterior and panuveitis of undetermined origin.
The main evaluation criterion will be the 12-month treatment effectiveness characterized by:
- No recurrence of inflammation in both eyes as assessed by the patient's referring ophthalmologist
- Oral corticosteroids <7.5 mg equivalent-prednisone
- No re-establishment of local corticosteroid therapy > or = at 2 drop/d
- No treatment stop due to intolerance or adverse reaction.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2022 (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 University Hospital, BrestThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370690
- Sponsor's protocol ID
- UMetAza (29BRC22.0039)
- Acronym
- UMetAza
- Status last verified
- Feb 2022
- First submitted
- 7 May 2022
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Comparison of the Efficacy of Methotrexate and Azathioprine as Background Treatment for Uveitis of Undetermined Origin: Single-centre Retrospective Study From 2005 to 2020
- ClinicalTrials.gov ID
- NCT05370690
- Acronym / sponsor ID
- UMetAza / UMetAza (29BRC22.0039)
- Conditions
- Uveitis
- Keywords
- Uveitis idiopatic (except anterior), azathioprine, methotrexate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 11 May 2022 (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.
Retrospective study at the Brest universitary hospital to evaluate the efficacy of methotrexate (MTX) and azathioprine (AZA) in background treatment of unidentified non anterior uveitis.
Detailed description
Uveitis is a major cause of ocular damage, responsible for 5 to 10% of blindness in the world. More broadly, up to 35% of patients with uveitis have visual acuity impairment ranging from "significant" to "legal blindness" [4]. The figures of "legal blindness" up to 25% according to the studies
The objective of any anti-inflammatory therapy strategy for uveitis is to:
- Quickly control eye inflammation to minimize irreversible structural damage and maintain visual function.
- Prevent inflammatory recurrences, which cause complications and co-morbidity.
- Limit the use of systemic corticosteroids over the course of their deleterious metabolic effects.
- Optimize the risk-benefit balance and promote compliance.
The studies concerning uveitis linked with another disease are multiple and are therefore well documented. Uveitis of undetermined origin is classified, by definition, as uveitis of non-infectious origin.
Anterior uveitis are available for local treatment prior to any discussion of introducing systemic treatment. Intermediate uveitis, posterior and panuveitis justify systemic treatment.
Systemic treatments used in these uveitis are METHOTREXATE, AZATHIOPRINE, MYCOPHENOLATE MOFETIL CICLOSPORINE, INTERFERON ALPHA, anti-TNF alpha. Antimetabolites (azathioprine, mycophenolate mofetil and methotrexate) are the most commonly used immunosuppressants.
Several randomized studies (retrospective or prospective) compared the use of METHOTREXATE (MTX) and MYCOPHENOLATE MOFETIL (MMF), in the management of non-infectious inflammatory ocular disease as a corticosteroid-sparing treatment.
Although MMF has a faster response time compared to MTX for inflammation control, the success rate is equivalent. These studies found no superiority of one molecule over the other .
There are no studies in the literature comparing the use of MTX versus AZA in treatment of these non-prior uveitis of undetermined origin. These two molecules are frequently used in our center as first-line treatment of idiopathic uveitis in an undifferentiated way.
The objective of this study is therefore to determine whether one of these molecules should be preferred for the management of our patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with uveitis (intermediate, posterior or panuveitis) of undetermined origin diagnosed and or followed between January 2005 and March 2020 at the CHRU of Brest and who received treatment with methotrexate or azathioprine.
Key inclusion criteria (3 listed)
- Patient age>18 years
- Intermediate, posterior or panuveitis diagnosed clinically by an ophthalmologist.
- Patient treated with azathioprine or methotrexate
Key exclusion criteria (7 listed)
- Patient under legal protection
- Methotrexate dose < 10mg or azathioprine < 50mg
- Systemic or ophthalmological disease (Behçet, sarcoidosis, Retinopathy of Birdshot, etc.)
- Infectious uveitis
- Ophthalmological surgery < 30 days
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
To compare the effectiveness of methotrexate versus azathioprine in controlling the inflammation of intermediate, posterior and panuveitis of undetermined origin.
Time frame: one year
The main evaluation criterion will be the 12-month treatment effectiveness characterized by: * No recurrence of inflammation in both eyes as assessed by the patient's referring ophthalmologist * Oral corticosteroids <7.5 mg equivalent-prednisone * No re-establishment of local corticosteroid therapy > or = at 2 drop/d * No treatment stop due to intolerance or adverse reaction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a 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. This study is not recruiting at the moment.
Xavier SAVARY 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, run by University Hospital, Brest 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 7 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: status not confirmed, as of the sponsor's last update on 11 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bénédicte ROUVIERE, PhD (02 98 34 73 36, benedicte.rouviere@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the effectiveness of methotrexate versus azathioprine in controlling the inflammation of intermediate, posterior and panuveitis of undetermined origin. (time frame: one year). 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 11 May 2022.