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

Overview

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).

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 13, 2019

Interventions

  • Drug: Alprostadil 20 micrograms
    • Intravenous infusion of PGE1 (Days 0, +1 and +2)
  • Drug: Placebo
    • Intravenous infusion of physiological saline solution

Arms, Groups and Cohorts

  • Experimental: Alprostadil 20 micrograms
    • 1 μg / kg patient weight up to a maximum of 60 μg
  • Placebo Comparator: Placebo (physiological saline solution)
    • Placebo (physiological saline solution)

Clinical Trial Outcome Measures

Primary Measures

  • determination of visual acuity
    • Time Frame: Change from baseline visual acuity at 90 days.
    • Test ETDRS (Early Treatment Diabetic Retinopathy Study)

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Rocio Hernandez Clares, MD, 968 369473., rociohclares@hotmail.com

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