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

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.

Timeline

Start

2010-10

Primary completion

2012-06

Completion

2012-06

Publications

• Niemeyer KM, Gonzales JA, Rathinam SR, Babu M, Thundikandy R, Kanakath A, Porco TC, Browne EN, Rao MM, Acharya NR. Quality-of-Life Outcomes From a Randomized Clinical Trial Comparing Antimetabolites for Intermediate, Posterior, and Panuveitis. Am J Ophthalmol. 2017 Jul;179:10-17. doi: 10.1016/j.ajo.2017.04.003. Epub 2017 Apr 14.

Drugs

Indications