NCT03851562Unknown2 期
Prospective, Unicentric, Randomized, Parallel, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate Intravenous Infusion of Prostaglandins as Therapy in Patients With Anterior Non-arteritic Ischemic Optic Neuropathy
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年6月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- determination of visual acuity
研究概览
简要总结
Correction of the deficit in the perfusion pressure of the microcirculation that supplies the nerve by intravenous infusion of Prostaglandin E1 (PGE1) (Alprostadil), expected to improve visual function in patients with ischemic optic neuropathy previous non-arteritic (NOIANA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients with previous optic of any etiology in the affected eye.
- •Patients with previous diagnosis or symptoms at the time of arteritis of the temporal artery.
- •Patients with optic neuropathy with bilateral clinical presentation of any etiology.
- •Patients with loss of vision due to acute hypotension in the context of a surgical intervention, acute hemorrhage or hemodynamic shock.
- •Patients with severe loss of previous vision in the eye affected by ophthalmologic causes: severe cataract, glaucoma or intraocular pressure greater than 30 millimeters of mercury, severe diabetic retinopathy, macular degeneration associated with severe age.
- •Patients with clinical onset in the month following major non-ocular or intraocular surgery
- •Patients with abnormal elevation of CRP / C-reactive protein (> 2 times the upper limit of normal)
- •Patients with creatinine levels above 1.5 mg / dL.
- •Patients on steroid treatment in the month prior to the episode.
- •Patients under treatment with oral anticoagulants.
- •Patients on treatment with hydroxychloroquine, ethambutol, vigabatrin at any time before the episode.
- •Patients in whom the use of PGE1 (Alprostadil) is contraindicated:
- •Patients with participation in a clinical trial in the last 6 months.
- •Patients with inability to understand informed consent.
- •Pregnant patients, in the postpartum period or during the active lactation period.
- •Physically fertile patients
研究组 & 干预措施
Alprostadil 20 micrograms
Experimental
1 μg / kg patient weight up to a maximum of 60 μg
干预措施: Alprostadil 20 micrograms (Drug)
Placebo (physiological saline solution)
Placebo Comparator
Placebo (physiological saline solution)
干预措施: Placebo (Drug)
结局指标
主要结局
determination of visual acuity
时间窗: Change from baseline visual acuity at 90 days.
Test ETDRS (Early Treatment Diabetic Retinopathy Study)
次要结局
- Hemodynamic indices of the ocular arteries(Day1,day+30 , day +90.)
- Visual Field(Day1,day+30 , day +90.)
- Number of Serious Adverse Events(Day 1, day +4,day+30 , day +90.)
- Thickness of the layer of nerve fibers and ganglion cells in the retina(Day1,day+30 , day +90.)
- fundoscopic evaluation(Day1,day+30 , day +90.)
- Intraocular Pressure(Day1,day+30 , day +90.)
- Optical disc area and cup / disc(Day1,day+30 , day +90.)
研究者
研究点 (1)
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