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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00918554
First received: June 9, 2009
Last updated: April 28, 2010
Last verified: April 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cumulated dose of prednisone [ Time Frame: at 26 weeks ] [ Designated as safety issue: No ]
  • Number of triamcinolone injections [ Time Frame: at 26 weeks ] [ Designated as safety issue: No ]
  • Adverse effects [ Time Frame: at 26 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with best corrected visual acuity under 0.1, 0.2 and 0. [ Time Frame: at 26 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with active anterior and /or posterior uveitis [ Time Frame: at 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918554

Contacts
Contact: Sébastien ABAD, MD 01-48-95-53-52 sebastien.abad@avc.aphp.fr

Locations
France
Hôpital Avicenne - Service de Médecine Interne Recruiting
Bobigny, France, 93009
Contact: Sébastien ABAD, MD     01-48-95-53-52     sebastien.abad@avc.aphp.fr    
Principal Investigator: Sébastien ABAD, MD            
CHU Michallon de Grenoble Recruiting
Grenoble, France, 38043
Contact: Laurence BOUILLET, MD     04 76 76 94 49 ext 55 20     lbouillet@chu-grenoble.fr    
Contact: Christophe CHIQUET, MD-PhD     04 76 76 52 71     cchiquet@chu-grenoble.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Sébastien ABAD, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Amel Ouslimani, Department of Clinical Research and development
ClinicalTrials.gov Identifier: NCT00918554     History of Changes
Other Study ID Numbers: P070140
Study First Received: June 9, 2009
Last Updated: April 28, 2010
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Edema
Macular Edema
Sarcoidosis
Uveitis
Chorioretinitis
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Uveal Diseases
Retinitis
Choroiditis
 Choroid Diseases
Uveitis, Posterior
Panuveitis
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013