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

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

Status and phase: Unknown; Phase 2

Conditions: Ischemic Optic Neuropathy

Treatments: Drug: Alprostadil 20 micrograms; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03851562

FFIS/PG/2017/03

Details and patient eligibility

About

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).

Enrollment: 24 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Alprostadil 20 micrograms

Experimental group

Description:

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

Treatment:

Drug: Alprostadil 20 micrograms

Placebo (physiological saline solution)

Placebo Comparator group

Description:

Placebo (physiological saline solution)

Treatment:

Drug: Placebo