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

Ischemic Optic Neuropathy Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03851562
• Other study ID #: FFIS/PG/2017/03
• Status: Recruiting
• Phase: Phase 2
• Start date: June 13, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: February 2019
• Source: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Contact: Rocio Hernandez Clares, MD
• Phone: 968 369473.
• Email: rociohclares[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: October 31, 2019
• Est. primary completion date: June 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Optic Neuropathy
• Optic Nerve Diseases
• Optic Neuritis
• Optic Neuropathy, Ischemic

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determination of visual acuity	Test ETDRS (Early Treatment Diabetic Retinopathy Study)	Change from baseline visual acuity at 90 days.
Secondary	Number of Serious Adverse Events	Adverse Event	Day 1, day +4,day+30 , day +90.
Secondary	Intraocular Pressure	Intraocular Pressure	Day1,day+30 , day +90.
Secondary	Visual Field	Humphrey Field Analyzer (HFA),	Day1,day+30 , day +90.
Secondary	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.
Secondary	fundoscopic evaluation	Biomicroscopy	Day1,day+30 , day +90.
Secondary	Hemodynamic indices of the ocular arteries	Doppler SIEMENS Antares™ System:	Day1,day+30 , day +90.
Secondary	Optical disc area and cup / disc	Cirrus , Carl Zeiss Meditec, Dublin, California, ver: 6.0.2.81:	Day1,day+30 , day +90.