First-line Antimetabolites as Steroid-sparing Treatment Uveitis Pilot Trial

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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-sparing treatment for patients with non-infectious uveitis requiring corticosteroid-sparing therapy.

One hundred non-infectious uveitis patients in need of corticosteroid-sparing therapy will be randomized to receive either oral methotrexate or oral mycophenolate mofetil at Aravind Eye Hospitals (Madurai and Coimbatore, South India). They will be followed monthly for 6 months after enrollment or until treatment failure. The investigators hypothesize that the proportion achieving corticosteroid-sparing success at 6 months for patients taking mycophenolate mofetil will be improved in comparison with patients taking methotrexate.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Aravind Eye Hospitals, India
• Treatments: Antimetabolites; Methotrexate; Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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