search
Back to results

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

Primary Purpose

Sarcoid-associated Uveitis, Ocular Sarcoidosis, Macular Edema

Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Methotrexate
Placebo
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoid-associated Uveitis focused on measuring Sarcoid-associated uveitis, Macular oedema, Methotrexate, Conventional corticosteroids sparing agent.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Avicenne - Service de Médecine Interne
  • CHU Michallon de Grenoble

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Methotrexate

Placebo

Arm Description

Outcomes

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.

Secondary Outcome Measures

Cumulated dose of prednisone
Number of triamcinolone injections
Adverse effects
Percentage of patients with best corrected visual acuity under 0.1, 0.2 and 0.
Percentage of patients with active anterior and /or posterior uveitis

Full Information

First Posted
June 9, 2009
Last Updated
May 30, 2014
Sponsor
Assistance Publique - Hôpitaux de Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT00918554
Brief Title
Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis
Acronym
UVEXATE
Official Title
Corticosteroid Sparing Effect of Methotrexate in Patients With Sarcoid- Associated Uveitis: A Double Blind, Randomized, Placebo Controlled-study -UVEXATE
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Why Stopped
insufficient number of inclusion
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoid-associated Uveitis, Ocular Sarcoidosis, Macular Edema
Keywords
Sarcoid-associated uveitis, Macular oedema, Methotrexate, Conventional corticosteroids sparing agent.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methotrexate
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Cumulated dose of prednisone
Time Frame
at 26 weeks
Title
Number of triamcinolone injections
Time Frame
at 26 weeks
Title
Adverse effects
Time Frame
at 26 weeks
Title
Percentage of patients with best corrected visual acuity under 0.1, 0.2 and 0.
Time Frame
at 26 weeks
Title
Percentage of patients with active anterior and /or posterior uveitis
Time Frame
at 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien ABAD, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Avicenne - Service de Médecine Interne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
CHU Michallon de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis

We'll reach out to this number within 24 hrs