Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis

Macular Edema Clinical Trial

— UVEXATE  

Official title:

Corticosteroid Sparing Effect of Methotrexate in Patients With Sarcoid- Associated Uveitis: A Double Blind, Randomized, Placebo Controlled-study -UVEXATE

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00918554
• Other study ID #: P070140
• Status: Terminated
• Phase: Phase 4
• First received: June 9, 2009
• Last updated: May 30, 2014
• Start date: September 2009
• Est. completion date: August 2010

Study information

• Verified date: June 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether methotrexate is a effective corticosteroid sparing agent in the treatment of sarcoid-associated uveitis.

Description:

Macular oedema remains a significant cause of blindness. Corticosteroids are effective in the treatment of sarcoid-associated macular oedema but more than 50% of relapses occur when corticosteroids are tapered. Methotrexate (MTX) at low dose has been shown to be an effective and safe steroid-sparing agent for lung sarcoidosis and compilation of reported small series of patients with sarcoid-associated uveitis suggest that only 25% of relapses could be achieved with low dose MTX. We decide therefore to test the clinical efficacy of MTX in sarcoid-associated uveitis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 years old

• Provided written consent for participation in the trial prior to any study-specific procedures or requirements

• Posterior uveitis or panuveitis associated with macular oedema defined as increased macular thickness (more than 250 mm assessed by Stratus TD-OCT or 300 mm with Cirrus SD-OCT ) and/or the presence of cystoid spaces in the macula, and the absence of epiretinal membranes.

• Patient with oral contraception

• Posterior uveitis or panuveitis associated with macular oedema

• Patients with histologically proven sarcoidosis or a presumed sarcoidosis. In case of a non caseating granuloma in biopsy tissues, the patients with presumed sarcoidosis meet at least 2 of the 4 following criteria: typical changes on chest radiography and computed tomography; predominantly CD4 lymphocytosis in bronchoalveolar lavage (BAL) fluid; elevated serum ACE levels; elevated gallium or 5 fluorodeoxyglucose uptake

Exclusion Criteria:

• Patients who do not fulfill the inclusion criteria

• Other causes of uveitis

• Extra ophthalmologic manifestations of sarcoidosis justifying corticosteroids

• Patients previously treated with immunosuppressive agents or corticosteroids of more than 10 mg daily over 15 days.

• Patients with life-threatening conditions

• Chronic hepatopathy or renal failure

• Uncontrolled diabetes mellitus

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Edema
• Ocular Sarcoidosis
• Sarcoid-associated Uveitis
• Sarcoidosis
• Uveitis

Intervention

Drug:
• Methotrexate
All patients will receive three pulses of methylprednisolone (5 mg/kg) followed by four weeks of prednisone (1 mg/kg daily). After randomization, patients will receive either prednisone (1 mg/kg daily) plus methotrexate (0.3 mg/kg weekly) or prednisone (1 mg/kg daily) plus placebo. Therapies will be administered orally. Corticosteroids will be progressively tapered when macular oedema completely resolve. Unilateral macular oedema relapses will be treated with a single local injection triamcinolone acetonide. Increasing dose of prednisone will be administered in case of bilateral macular oedema relapses.
• Placebo
All patients will receive three pulses of methylprednisolone (5 mg/kg) followed by four weeks of prednisone (1 mg/kg daily). After randomization, patients will receive either prednisone (1 mg/kg daily) plus methotrexate (0.3 mg/kg weekly) or prednisone (1 mg/kg daily) plus placebo. Therapies will be administered orally. Corticosteroids will be progressively tapered when macular oedema completely resolve. Unilateral macular oedema relapses will be treated with a single local injection of triamcinolone acetonide. Increasing dose of prednisone will be administered in case of bilateral macular oedema relapses.

Locations

Country	Name	City	State
France	Hôpital Avicenne - Service de Médecine Interne	Bobigny
France	CHU Michallon de Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of macular oedema relapses. Every two weeks for five months, the amount of macular oedema will be assessed by Optical Coherence Tomography.		at 26 weeks	No
Secondary	Cumulated dose of prednisone		at 26 weeks	No
Secondary	Number of triamcinolone injections		at 26 weeks	No
Secondary	Adverse effects		at 26 weeks	No
Secondary	Percentage of patients with best corrected visual acuity under 0.1, 0.2 and 0.		at 26 weeks	No
Secondary	Percentage of patients with active anterior and /or posterior uveitis		at 26 weeks	No