This is a randomized masked pilot trial of Zenapax (a humanized anti-Tac antibody) vs placebo combined with standard therapy in the treatment of the ocular complications of Behcet's disease. The primary goal of the study is to investigate the safety and efficacy of Zenapax in controlling the recurrent explosive nature of ocular manifestations in patients with Behcet's disease. Twenty adult patients will be randomly assigned. In addition 6 children with Behcet?s disease are also being recruited. The primary efficacy outcomes of the study are based on the number of ocular attacks experienced and the amount of immunosuppressive medications over the 2 year study period. Secondary efficacy outcomes include the level of inflammation. This study continues to actively recruit patients. The results are monitored by the NEI Data and Safety Monitoring Committee. Since it is an ongoing masked study, there are no results to report.
| Li, Zhuqing; Mahesh, Sankaranarayana P; Kim, Ben J et al. (2003) Expression of glucocorticoid induced TNF receptor family related protein (GITR) on peripheral T cells from normal human donors and patients with non-infectious uveitis. J Autoimmun 21:83-92 |
