Treatment of Uveitic Macular Edema with Intravitreal Methotrexate (11-ei-0107)

National Eye Institute

Investigators

Abstract

The total enrollment goal for this study is seven participants. Five participants with uveitic macular edema determined on OCT will be initially enrolled and included in the primary analysis. An additional two participants may be enrolled to account for participants who withdraw from the study prior to Week 12. ERG will be performed to assess the afety of multiple intravitreal injections of methotrexate in uveitis patients. To date, two Caucasian female participants of Non-Hispanic origin have been enrolled. One participant has been enrolled since the last continuing review. Participant 001 has completed the induction phase of the protocol and is currently in the PRN phase of the protocol. Participant 002 was enrolled on November 10, 2011 and is also currently in the PRN phase of the protocol. Accrual for this study has been satisfactory given that recruitment was temporarily halted due to a temporary shortage of the leucovorin drug supply. We are continuing to screen patients for enrollment in order to recruit the needed number of participants. No samples are stored for this study. To date, no serious adverse events have been reported.