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.
- Conditions
- on-arteritic anterior ischemic optic neuropathy (NOIANA).Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2017-004982-28-ES
- Lead Sponsor
- Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 24
• 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
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method