EUCTR2017-004982-28-ES进行中（未招募）1 期
Phase IIb prospective, unicentric, randomized, parallel, double-blind, placebo-controlled clinical trial to evaluate the intravenous infusion of prostaglandins as therapy in patients with non-arteritic anterior ischemic optic neuropathy. - PG-NAIO
Fundación para la Formación e Investigación Sanitarias de la Región de Murcia0 个研究点目标入组 24 人开始时间: 2018年3月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients of both sexes between the ages of 50 and 80, both inclusive.
- •Patients with the first episode of NOIANA.
- •Patients with NOIANA with a time of evolution from the beginning of the clinic less than or equal to 15 days.
- •Potentially fertile patients should have a negative pregnancy test in serum or urine.
- •Patients who offer sufficient guarantees of adherence to the protocol.
- •Patients who give written informed consent to participate in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •Patients with previous optic neuropathy of any etiology in the affected eye.
- •Patients with previous diagnosis or signs / 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 mmHg, severe diabetic retinopathy, macular degeneration associated with severe age.
- •Patients with clinical onset in the month following major non-ocular or intraocular surgery, except phakectomy.
- •Patients with abnormal elevation of ESR or CRP (> 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:
- •- Hypersensitivity to Alprostadil or to any of the excipients.
- •- Cardiac insufficiency grade III-IV of the NYH.
- •- Inadequately treated heart failure or coronary artery disease.
- •- Alteration of the hemodynamically relevant cardiac rhythm.
- •- Myocardial infarction or stroke in the 6 months prior to the start of treatment.
- •- Severe hypotension.
- •- Clinical or radiological signs of acute pulmonary edema or patients with a history of heart failure who have developed pulmonary edema.
- •- Severe chronic obstructive pulmonary disease (COPD) or pulmonary veno-occlusive disease (PVOD).
- •- Signs of acute liver injury (elevated transaminases and gamma GT) or with a history of severe liver injury.
- •- Patients in whom complications due to bleeding can be expected (eg, recent gastrointestinal ulcer, multiple trauma.
- •- Stenosis and / or insufficiency of the aortic valve or miter.
- •Patients with participation in a clinical trial in the last 6 months.
- •Patients with inability to understand informed consent.
- •Pregnant patients, in postpartum period or during active lactation period.
- •Physically fertile patients, defined as all women physiologically capable of becoming pregnant, including women whose track record, lifestyle or sexual orientation excludes intercourse with a male and women whose partners have been sterilized with vasectomy or other methods, NOT TO BE WHO are using a reliable contraceptive method (see Appendix C). This contraceptive method can be:
- •- Complete abstinence from sexual intercourse
- •- Surgical sterilization (tubal ligation)
- •- Surgical sterilization of the couple (vasectomy)
- •- Oral implanted or injectable hormonal contraceptives *
- •* Because hormonal contraceptives present a risk of thrombosis, other effective contraceptive methods should be considered.
- •These reliable contraceptive methods must be maintained during your participation in the study.
研究者
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