Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis

NCT00918554 | Terminated Phase 4

• 1 other identifier: P070140
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Sarcoid-associated Uveitis; Ocular Sarcoidosis; Macular Edema

Keywords

Sarcoid-associated uveitis; Macular oedema; Methotrexate; Conventional corticosteroids sparing agent.

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Cumulated dose of prednisone

  at 26 weeks

• Number of triamcinolone injections

  at 26 weeks

• Adverse effects

  at 26 weeks

• Percentage of patients with best corrected visual acuity under 0.1, 0.2 and 0.

  at 26 weeks

• Percentage of patients with active anterior and /or posterior uveitis

  at 26 weeks

Study Arms (2)

Methotrexate

EXPERIMENTAL

Drug: Methotrexate

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Methotrexate DRUG

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.

Methotrexate

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Hôpital Avicenne - Service de Médecine Interne

Bobigny, 93009, France

Location

CHU Michallon de Grenoble

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Macular Edema

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sébastien ABAD, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 11, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: June 2, 2014

Record last verified: 2013-06

Locations

FR (2)