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

NCT ID: NCT05370690

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-11-01

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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Brest

Brest, , France

Countries

France

Central Contacts

Bénédicte ROUVIERE, PhD

Role: CONTACT

benedicte.rouviere@chu-brest.fr

02 98 34 73 36

Xavier SAVARY

Role: CONTACT

xavier.savary@chu-brest.fr

Facility Contacts

Benedicte ROUVIERE

Role: primary

benedicte.rouviere@chu-brest.fr

Other Identifiers

UMetAza (29BRC22.0039)

Identifier Type: -

Identifier Source: org_study_id