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

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

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).

Study Overview

• Status: Unknown
• Conditions: Ischemic Optic Neuropathy
• Intervention / Treatment: Drug: Alprostadil 20 micrograms; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rocio Hernandez Clares, MD; Phone Number: 968 369473.; Email: rociohclares@hotmail.com

Study Locations

• Spain
  • Murcia, Spain, 30120
    • Recruiting
    • Hospital Clinico Universitario Virgen de la Arrixaca
    • Contact: Servicio de Neurología.; Phone Number: 968369473
    • Principal Investigator: Rocio Hernandez Clares, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2018
• Primary Completion (Anticipated): June 13, 2019
• Study Completion (Anticipated): October 31, 2019

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 22, 2019

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 22, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ischemia; Optic Nerve Diseases; Optic Neuropathy, Ischemic; Vasodilator Agents; Urological Agents; Platelet Aggregation Inhibitors; Alprostadil
• Other Study ID Numbers: FFIS/PG/2017/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No