Intravenous Infusion of Prostaglandins as Therapy in Patients With Anterior Non-arteritic Ischemic Optic Neuropathy

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Ischemic Optic Neuropathy

Intervention / Treatment
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* Drug: Alprostadil 20 micrograms
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients of both sexes between the ages of 50 and 80, both inclusive. Patients with the first episode of ischemic optic neuropathy previous non-arteritic / NOIANA. Patients with NOIANA with an evolution time from the beginning of the clinic less than or equal to 15 days. Potentially fertile patients should have a negative pregnancy test in serum (beta-HCG / human chorionic gonadotropin) or urine. Patients who offer sufficient guarantees of adherence to the protocol. Patients who give written informed consent to participate in the study. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alprostadil 20 micrograms<br>1 μg / kg patient weight up to a maximum of 60 μg | Drug: Alprostadil 20 micrograms<br>* Intravenous infusion of PGE1 (Days 0, +1 and +2)<br>|
| Placebo Comparator: Placebo (physiological saline solution)<br>Placebo (physiological saline solution) | Drug: Placebo<br>* Intravenous infusion of physiological saline solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determination of visual acuity | Test ETDRS (Early Treatment Diabetic Retinopathy Study) | Change from baseline visual acuity at 90 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Serious Adverse Events | Adverse Event | Day 1, day +4,day+30 , day +90. | 
| Intraocular Pressure | Intraocular Pressure | Day1,day+30 , day +90. | 
| Visual Field | Humphrey Field Analyzer (HFA), | Day1,day+30 , day +90. | 
| Thickness of the layer of nerve fibers and ganglion cells in the retina | Cirrus , Carl Zeiss Meditec, Dublin, California, ver: 6.0.2.81: | Day1,day+30 , day +90. | 
| fundoscopic evaluation | Biomicroscopy | Day1,day+30 , day +90. | 
| Hemodynamic indices of the ocular arteries | Doppler SIEMENS Antares™ System: | Day1,day+30 , day +90. | 
| Optical disc area and cup / disc | Cirrus , Carl Zeiss Meditec, Dublin, California, ver: 6.0.2.81: | Day1,day+30 , day +90. |