Non-arteritic anterior ischemic optic neuropathy (NOIANA).
Conditions
Interventions
Trade Name: Alprostadil
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Prostaglandin E1
CAS Number: UK82077500
Other descriptive name: PROSTAGLANDIN E1, LIPID-ENCAPSULATED
Sponsors
Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of the intravenous infusion of PGE1 (Alprostadil) to improve the visual function of patients with NOIANA. • Visual acuity assessed with ETDRS (Early Treatment Diabetic Retinopathy Study) test;Secondary Objective: To assess the safety of the intravenous infusion of PGE1 (Alprostadil) in patients with NOIANA. • Serious adverse events with possible, probable or safe relationship with the procedure. • Non-serious adverse events with possible, probable or safe relationship with the procedure. To analyze the effects of intravenous infusion of PGE1 (Alprostadil) in the evolution of patients with NOIANA based on the following criteria. • Intraocular pressure assessed with applanation tonometry • Visual field valued with Humphrey campimetry. • Thickness of the layer of nerve fibers and ganglion cells of the retina assessed with optical coherence tomography. • Fund of eye valued with biomicroscopy. • Hemodynamic indices of the ocular arteries assessed with transorbital Doppler ultrasound. Study the characteristics of the optic disc of the affected eye and the contralateral: • Optical disc area and cup / disc ratio assessed with optical coherence tomography.;Primary end point(s): Efficacy assessment: •Visual acuity ETDRS (Early Treatment Diabetic Retinopathy Study) Test: It allows to determine the best monocular visual acuity in mesopic conditions, for it the illuminated box ESV-3000, which allows the photopic and mesopic illumination (85 cd / m2 or 3 cd / m2) will be used. . It will be done at 4 m and 1 m when the patient read less than 15 letters at 4 m. The test will end when the patient is unable to read all the letters of a line (5), collecting the total number of letters correctly identified until that moment. Subsequently, the AV will be moved from the number of letters read to the LogMar Scale (+1.0, -0.3) for far vision with correction. - Visual acuity with correction (AVcc) - distant vision: Nº letters, LogMar.;Timepoint(s) o | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Security assessment: • Rate of serious adverse events with possible, probable or defined relationship with the procedure. • Rate of non-serious adverse events with possible, probable or defined relationship with the procedure. Assessment of the evolution of the disease: • Optical disc area and cup / disc ratio •Visual field • Thickness of the layer of nerve fibers and ganglion cells of the retina • Fund of eye • Hemodynamic indices of the ocular arteries •Intraocular pressure;Timepoint(s) of evaluation of this end point: Safety assessment: AA and AAG In all study visits once the informed consent has been signed. Assessment of the evolution of the disease: • Intraocular pressure: It will be done at the screening visit, at 30 days and at 3 months. • Visual field: It will be done at the screening visit, at 30 days and at 3 months. • Thickness of the layer of nerve fibers and ganglion cells of the retina: This will be done at the screening visit, at 30 days and at 3 months. • Fund of eye: It will be realized in the visit of selection, to the 30 days and to the 3 months. • Hemodynamic indices of the ocular arteries: This will be done during the screening visit and the day after finishing the treatment. • Area of the optical disc and cup / disc ratio: It will be done in the selection visit. | — |
Countries
Spain
Contacts
Public ContactUICEC
Fundación para la Formación e Investigación Sanitaria de la Región de Murcia
Outcome results
None listed