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Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis (UVEXATE)

This study has been terminated.
(insufficient number of inclusion)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00918554
First Posted: June 11, 2009
Last Update Posted: June 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
The purpose of this study is to determine whether methotrexate is a effective corticosteroid sparing agent in the treatment of sarcoid-associated uveitis.

Condition Intervention Phase
Sarcoid-associated Uveitis Ocular Sarcoidosis Macular Edema Drug: Methotrexate Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Corticosteroid Sparing Effect of Methotrexate in Patients With Sarcoid- Associated Uveitis: A Double Blind, Randomized, Placebo Controlled-study -UVEXATE

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Percentage of macular oedema relapses. Every two weeks for five months, the amount of macular oedema will be assessed by Optical Coherence Tomography. [ Time Frame: at 26 weeks ]

Secondary Outcome Measures:
  • Cumulated dose of prednisone [ Time Frame: at 26 weeks ]
  • Number of triamcinolone injections [ Time Frame: at 26 weeks ]
  • Adverse effects [ Time Frame: at 26 weeks ]
  • Percentage of patients with best corrected visual acuity under 0.1, 0.2 and 0. [ Time Frame: at 26 weeks ]
  • Percentage of patients with active anterior and /or posterior uveitis [ Time Frame: at 26 weeks ]

Enrollment: 7
Study Start Date: September 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methotrexate 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 Comparator: Placebo Drug: 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.

Detailed 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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00918554


Locations
France
Hôpital Avicenne - Service de Médecine Interne
Bobigny, France, 93009
CHU Michallon de Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Sébastien ABAD, MD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00918554     History of Changes
Other Study ID Numbers: P070140
First Submitted: June 9, 2009
First Posted: June 11, 2009
Last Update Posted: June 2, 2014
Last Verified: June 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Sarcoid-associated uveitis
Macular oedema
Methotrexate
Conventional corticosteroids sparing agent.

Additional relevant MeSH terms:
Macular Edema
Uveitis
Sarcoidosis
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Uveal Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Methotrexate
Triamcinolone Acetonide
Methylprednisolone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents
Antiemetics