NCT00959725Unknown1 期
Pilot Study for the Evaluation of Intravitreal Infliximab in the Treatment of Diabetic Macular Edema
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Best-corrected visual acuity
研究概览
简要总结
The purpose of this study is to determine if intravitreal infliximab is a safe and effective treatment for macular edema secondary to diabetes.
详细描述
Participants with diabetic macular edema will be treated with one injection of intravitreal infliximab (2.0mg/0.05ml) and followed for three months. Outcomes that be assessed include best-corrected visual acuity, macular thickness as measured by optical coherence tomography, and electroretinogram responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be 18 years of age or older.
- •Participant has DME that is not amenable to treatment with laser photocoagulation or has been refractory to laser photocoagulation.
- •Participant must have a negative PPD skin test.
- •Participant must understand and sign the protocol's informed consent document.
- •Participants must have DME as defined by all of the following criteria:
- •Presence of diabetes (type I or type II)
- •Macular edema defined as a central macular thickness of ≥ 250μm on OCT.
- •Participant must have visual acuity between 20/40 and hand motions in the study eye.
- •Participant must have a steady fixation in the study eye and media clear enough for good quality imaging.
- •Female participants of childbearing potential must not be pregnant or breast-feeding, must have a negative pregnancy test at screening and must practice an adequate method of birth control. Males able to father a child must agree to practice birth control. Acceptable methods of birth control include hormonal contraception (birth control pills, injected hormones or vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom and spermicide) or surgical sterilization (hysterectomy, tubal ligation or vasectomy in a partner). If a participant is of childbearing potential, she must be willing to undergo monthly urine pregnancy tests. Both males and females must agree to use adequate birth control for three months after the intravitreal infliximab injection.
- •If both eyes of a participant qualify for inclusion, then the eye with worse visual acuity will be chosen.
排除标准
- •Participant is in another investigational study and actively receiving study therapy.
- •Participant has proliferative diabetic retinopathy.
- •Participant is unable to comply with study procedures or follow-up visits.
- •Participant has multiple sclerosis or symptoms suggestive of multiple sclerosis.
- •Participant has evidence of ocular disease other than DME in either eye that may confound the outcome of the study (e.g., uveitis, age-related macular degeneration, vitreomacular traction, moderate/severe myopia, etc.).
- •Participant is expected to need ocular surgery or panretinal photocoagulation in the study eye during the course of the study.
- •Participant has undergone ocular surgery or an intravitreal/periocular steroid injection in the study eye within the past 3 months.
- •Participant has had a YAG laser capsulotomy or intravitreal anti-VEGF treatment in the study eye within the past 6 weeks.
- •Participant has had a pars plana vitrectomy in the study eye.
- •Participant is on ocular or systemic medications known to be toxic to the lens, retina, or optic nerve.
- •Participant with a history of ocular herpes simplex virus infection in the study eye.
- •A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).
研究组 & 干预措施
Intravitreal infliximab.
Experimental
干预措施: Infliximab (intravitreal, 2.0mg/0.05ml) (Drug)
结局指标
主要结局
Best-corrected visual acuity
时间窗: Three months
次要结局
- Macular thickness(One, two, and three months)
研究者
研究点 (1)
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