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

这项研究的总招生目标是7名参与者。五名在OCT上确定患有葡萄膜黄斑水肿的参与者将最初登记并纳入初步分析。另外两名参与者可能会被招募，以说明在12周前退出研究的参与者。将进行ERG以评估葡萄膜炎患者多次玻璃体内注射甲氨蝶呤的安全性。 迄今为止，已登记了两名非西班牙裔高加索女性参与者。自上次持续审查以来，已有一名参与者报名参加。参与方001已经完成了议定书的归纳阶段，目前正处于议定书的PRN阶段。参与者002于2011年11月10日注册，目前也处于方案的PRN阶段。 考虑到由于亚叶酸钙药物供应暂时短缺，招募工作暂时停止，这项研究的收益令人满意。我们正在继续对患者进行登记筛选，以便招募到所需数量的参与者。 本研究不储存任何样本。 到目前为止，还没有严重不良事件的报告。

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.