NT-501 CNTF Implant for Ischemic Optic Neuropathy: Safety, Neuroprotection and Neuroenhancement
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Safety: Number of patients with adverse events
研究概览
简要总结
Ciliary Neurotrophic Factor (CNTF) has been demonstrated in multiple preclinical models to enhance survival and regeneration of retinal ganglion cells, the retinal neurons injured in diseases like ischemic optic neuropathy/optic nerve stroke. We hypothesize that CNTF delivery to the human eye will provide neuroprotection (prevent loss of vision) and neuroenhancement (improve vision indices) in ischemic optic neuropathy. Patients in the trial will receive an NT-501 CNTF implant (made by Neurotech) into one eye, and will be carefully followed to evaluate safety and efficacy.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 40 years or older
- •must understand and sign the informed consent
- •must be medically able to undergo ophthalmic surgery for the NT-501 device insertion and possible removal, as well as the testing required.
- •diagnosis of ischemic optic neuropathy characterized by (a) non-arteritic subtype, including a normal ESR and CRP; (b) syndrome of acute unilateral visual loss with documented optic nerve head edema but without significant pain; (c) a relative afferent papillary defect in the affected eye, and a decrease of best-corrected visual acuity to 20/40 or worse in the affected eye, and detectable loss on visual field testing consistent with nerve fiber visual field defect but retaining measurable residual visual field preservation.
排除标准
- •other corneal, lens, optic nerve or retinal disease causing vision loss,
- •blind in one eye
- •requirement of acyclovir and/or related products during study
- •receiving systemic steroids or other immunosuppressive medications.
- •pregnant or lactating.
- •considered immunodeficient or has a known history of human immunodeficiency virus (HIV)
- •on chemotherapy, or a history of malignancy, UNLESS it was treated successfully 2 years prior to inclusion in the trial.
研究组 & 干预措施
NT-501 CNTF Implant
Patients will receive single NT-501 CNTF implant in one eye
干预措施: NT-501 CNTF Implant (Drug)
结局指标
主要结局
Safety: Number of patients with adverse events
时间窗: 18 months
Safety will be evaluated by determining the number of patients with adverse events, including loss of vision, visual field, or retinal/optic nerve structure, and ocular complications such as pain and inflammation.
次要结局
- Functional Efficacy: Vision, Visual Field, Pattern Electroretinogram, Visual Field Questionnaire-25(18 months)
- Structural efficacy: Nerve fiber layer, optic nerve topography(18 months)
研究者
Jeffrey L Goldberg
Associate Professor of Ophthalmology
Stanford University