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

玻璃体内注射甲氨蝶呤治疗葡萄膜炎性黄斑水肿 (11-ei-0107)

• 批准号: 8938357
• 负责人: Hatice Sen
• 金额: $ 2.42万
• 依托单位: NATIONAL EYE INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8938357
• 关键词: Accounting; Adverse event; Caucasians; Caucasoid Race; Chronic; Clinical; Clinical Trials; Diabetic Retinopathy; Dose; Early treatment; Electroretinography; Eligibility Determination; Enrollment; Evaluation; Extravasation; Eye; Female; Fluorescein Angiography; Fundus; Goals; Image; Immunosuppression; Inflammation; Injection of therapeutic agent; Intermediate Uveitis; Leucovorin; Methotrexate; Not Hispanic or Latino; Outcome; Outcome Measure; Panuveitis; Participant; Patients; Pattern; Pharmaceutical Preparations; Phase; Population Study; Posterior Uveitis; Protocols documentation; Recruitment Activity; Recurrence; Reporting; Retinal; Safety; Sampling; Secondary to; Serious Adverse Event; Severities; Steroids; Therapeutic immunosuppression; Thick; Toxic effect; Uveitis; Visit; Visual Acuity; Withdrawal; design; experience; intravitreal injection; macula; macular edema; meetings; primary outcome; prospective; secondary outcome; success

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.

本研究的总招募目标是七名参与者。最初将招募五名经 OCT 确定患有葡萄膜炎黄斑水肿的参与者并纳入主要分析。考虑到在第 12 周之前退出研究的参与者，可能会另外招募两名参与者。将进行 ERG 来评估葡萄膜炎患者多次玻璃体内注射甲氨蝶呤的有效性。 迄今为止，已有两名非西班牙裔白人女性参与者入组。自上次持续审查以来已登记一名参与者。参与者 001 已完成协议的诱导阶段，目前处于协议的 PRN 阶段。参与者 002 于 2011 年 11 月 10 日注册，目前也处于协议的 PRN 阶段。 鉴于由于甲酰四氢叶酸药物供应暂时短缺而暂时停止招募，本研究的应计费用令人满意。我们正在继续筛选患者入组，以招募所需数量的参与者。 本研究未存储任何样本。 迄今为止，尚未报告严重不良事件。