Status:
COMPLETED
First-line Antimetabolites as Steroid-sparing Treatment Uveitis Pilot Trial
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Aravind Eye Hospitals, India
Conditions:
Uveitis
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The proposed study is a masked trial, with stratified block randomization by site, designed to determine which treatment, methotrexate or mycophenolate mofetil, is more effective as first-line steroid...
Detailed Description
Uveitis, a set of conditions defined by intraocular inflammation, is a significant cause of vision loss and morbidity in the United States and the world. The incidence was recently estimated to be mor...
Eligibility Criteria
Inclusion
- Non-infectious anterior, intermediate, posterior or panuveitis
- Active uveitis within the last 60 days (defined by the presence of any of the following according to SUN criteria: ≥ 1+ anterior chamber cells, anterior vitreous cells, vitreous haze, active retinal or choroidal lesions)
- Prednisone dose ≥ 15 mg/day
- History of corticosteroid taper failure (inability to taper to prednisone 10 mg or less) or obvious chronic disease necessitating corticosteroid-sparing immunosuppressive treatment
Exclusion
- Any infectious cause of uveitis
- Tuberculosis: Evidence of active TB (PPD and CXR required - latent TB patients are still eligible)
- Positive for Hepatitis: HBsAg and/or Hep C antibody
- Positive for Syphilis: RPR/VDRL and/or FTA-ABS
- Abnormal CBC (\<2500 WBC or \<75,000 Plts or \<10 Hgb)
- Abnormal liver and/or kidney tests (ALT/AST \>2x normal or CR\>1.5)
- Pregnancy or breast-feeding (blood or urine pregnancy test for all females, excluding those who are post-menopausal)
- Chronic hypotony (IOP \< 5 mm Hg for \> 3 months)
- Prior use of any immunosuppressive drug for the treatment of uveitis in the past 6 months
- Prior failed treatment with methotrexate or mycophenolate mofetil
- Periocular or intravitreal corticosteroid injection in the past 3 months
- Fluocinolone acetonide implant surgery in either eye in \< 3 years
- Intraocular surgery in \< 30 days, or any ocular surgery scheduled during the 6-month study period
- VA of hand motions or worse in better eye
- \< 16 years of age at enrollment
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01232920
Start Date
October 1 2010
End Date
June 1 2012
Last Update
July 15 2016
Active Locations (2)
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1
Aravind Eye Hospital
Coimbatore, Tamil Nadu, India
2
Aravind Eye Hospital
Madurai, Tamil Nadu, India