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

Primary Purpose

Ischemic Optic Neuropathy

Status

Unknown status

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Alprostadil 20 micrograms

Placebo

About this trial

This is an interventional treatment trial for Ischemic Optic Neuropathy

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital Clínico Universitario Virgen de la ArrixacaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Alprostadil 20 micrograms

Placebo (physiological saline solution)

Arm Description

1 μg / kg patient weight up to a maximum of 60 μg

Placebo (physiological saline solution)

Outcomes

Primary Outcome Measures

determination of visual acuity

Test ETDRS (Early Treatment Diabetic Retinopathy Study)

Secondary Outcome Measures

Number of Serious Adverse Events

Adverse Event

Intraocular Pressure

Visual Field

Humphrey Field Analyzer (HFA),

Thickness of the layer of nerve fibers and ganglion cells in the retina

Cirrus , Carl Zeiss Meditec, Dublin, California, ver: 6.0.2.81:

fundoscopic evaluation

Biomicroscopy

Hemodynamic indices of the ocular arteries

Doppler SIEMENS Antares™ System:

Optical disc area and cup / disc

Cirrus , Carl Zeiss Meditec, Dublin, California, ver: 6.0.2.81:

Full Information

NCT ID

NCT03851562

First Posted

January 11, 2019

Last Updated

February 22, 2019

Sponsor

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

1. Study Identification

Unique Protocol Identification Number

NCT03851562

Brief Title

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

Acronym

PG-NAION

Official Title

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

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 13, 2018 (Actual)

Primary Completion Date

June 13, 2019 (Anticipated)

Study Completion Date

October 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Optic Neuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Alprostadil 20 micrograms

Arm Type

Experimental

Arm Description

1 μg / kg patient weight up to a maximum of 60 μg

Arm Title

Placebo (physiological saline solution)

Arm Type

Placebo Comparator

Arm Description

Placebo (physiological saline solution)

Intervention Type

Drug

Intervention Name(s)

Alprostadil 20 micrograms

Intervention Description

Intravenous infusion of PGE1 (Days 0, +1 and +2)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Intravenous infusion of physiological saline solution

Primary Outcome Measure Information:

Title

determination of visual acuity

Description

Test ETDRS (Early Treatment Diabetic Retinopathy Study)

Time Frame

Change from baseline visual acuity at 90 days.

Secondary Outcome Measure Information:

Title

Number of Serious Adverse Events

Description

Adverse Event

Time Frame

Day 1, day +4,day+30 , day +90.

Title

Intraocular Pressure

Description

Intraocular Pressure

Time Frame

Day1,day+30 , day +90.

Title

Visual Field

Description

Humphrey Field Analyzer (HFA),

Time Frame

Day1,day+30 , day +90.

Title

Thickness of the layer of nerve fibers and ganglion cells in the retina

Description

Cirrus , Carl Zeiss Meditec, Dublin, California, ver: 6.0.2.81:

Time Frame

Day1,day+30 , day +90.

Title

fundoscopic evaluation

Description

Biomicroscopy

Time Frame

Day1,day+30 , day +90.

Title

Hemodynamic indices of the ocular arteries

Description

Doppler SIEMENS Antares™ System:

Time Frame

Day1,day+30 , day +90.

Title

Optical disc area and cup / disc

Description

Cirrus , Carl Zeiss Meditec, Dublin, California, ver: 6.0.2.81:

Time Frame

Day1,day+30 , day +90.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rocio Hernandez Clares, MD

Phone

968 369473.

rociohclares@hotmail.com

Facility Information:

Facility Name

Hospital Clínico Universitario Virgen de la Arrixaca

City

Murcia

ZIP/Postal Code

30120

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Servicio de Neurología.

Phone

968369473

First Name & Middle Initial & Last Name & Degree

Rocio Hernandez Clares, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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