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

Uveitis Clinical Trial

— UMetAza  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05370690
• Other study ID #: UMetAza (29BRC22.0039)
• Status: Not yet recruiting
• Start date: May 1, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: February 2022
• Source: University Hospital, Brest
• Contact: Bénédicte ROUVIERE, PhD
• Phone: 02 98 34 73 36
• Email: benedicte.rouviere[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Uveitis

Locations

Country	Name	City	State
France	CHU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one year