Clinical trial NCT03851562: Intravenous Infusion of Prostaglandins as Therapy in Patients With Anterior Non-arteritic Ischemic Optic Neuropathy
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ischemic Optic Neuropathy
Lead sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: determination of visual acuity
timeFrame: Change from baseline visual acuity at 90 days.
Secondary outcomes:
measure: Number of Serious Adverse Events
timeFrame: Day 1, day +4,day+30 , day +90.
measure: Intraocular Pressure
timeFrame: Day1,day+30 , day +90.
measure: Visual Field
timeFrame: Day1,day+30 , day +90.
measure: Thickness of the layer of nerve fibers and ganglion cells in the retina
timeFrame: Day1,day+30 , day +90.
measure: fundoscopic evaluation
timeFrame: Day1,day+30 , day +90.
measure: Hemodynamic indices of the ocular arteries
timeFrame: Day1,day+30 , day +90.
measure: Optical disc area and cup / disc
timeFrame: Day1,day+30 , day +90.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
Study officials:
References: