Ischemic Optic Neuropathy
Conditions
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).
Interventions
Intravenous infusion of PGE1 (Days 0, +1 and +2)
DRUGPlacebo
Intravenous infusion of physiological saline solution
Sponsors
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| determination of visual acuity | Change from baseline visual acuity at 90 days. | Test ETDRS (Early Treatment Diabetic Retinopathy Study) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Serious Adverse Events | Day 1, day +4,day+30 , day +90. | Adverse Event |
| Intraocular Pressure | Day1,day+30 , day +90. | Intraocular Pressure |
| Visual Field | Day1,day+30 , day +90. | Humphrey Field Analyzer (HFA), |
| Hemodynamic indices of the ocular arteries | Day1,day+30 , day +90. | Doppler SIEMENS Antares™ System: |
| fundoscopic evaluation | Day1,day+30 , day +90. | Biomicroscopy |
| Optical disc area and cup / disc | Day1,day+30 , day +90. | Cirrus , Carl Zeiss Meditec, Dublin, California, ver: 6.0.2.81: |
| Thickness of the layer of nerve fibers and ganglion cells in the retina | Day1,day+30 , day +90. | Cirrus , Carl Zeiss Meditec, Dublin, California, ver: 6.0.2.81: |
Countries
Spain
Contacts
Primary ContactRocio Hernandez Clares, MD
Outcome results
None listed