Status:
UNKNOWN
Intravenous Infusion of Prostaglandins as Therapy in Patients With Anterior Non-arteritic Ischemic Optic Neuropathy
Lead Sponsor:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Conditions:
Ischemic Optic Neuropathy
Eligibility:
All Genders
50-80 years
Phase:
PHASE2
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 functio...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03851562
Start Date
June 13 2018
End Date
October 31 2019
Last Update
February 25 2019
Active Locations (1)
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1
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain, 30120