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UMetAza: 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

Sponsor
University Hospital, Brest (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05370690
Collaborator
(none)
70
Enrollment
1
Location
6
Anticipated Duration (Months)
11.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    70 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    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
    Anticipated Study Start Date :
    May 1, 2022
    Anticipated Primary Completion Date :
    Nov 1, 2022
    Anticipated Study Completion Date :
    Nov 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. To compare the effectiveness of methotrexate versus azathioprine in controlling the inflammation of intermediate, posterior and panuveitis of undetermined origin. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patient age>18 years

    • Intermediate, posterior or panuveitis diagnosed clinically by an ophthalmologist.

    • Patient treated with azathioprine or methotrexate

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Brest Brest France 29609

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT05370690
    Other Study ID Numbers:
    • UMetAza (29BRC22.0039)
    First Posted:
    May 11, 2022
    Last Update Posted:
    May 11, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Brest
    Uveitis idiopatic (except anterior), azathioprine, methotrexate
    Additional relevant MeSH terms:
    Uveitis

    Study Results

    No Results Posted as of May 11, 2022