Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alprostadil 20 micrograms | Experimental | 1 ÎĽg / kg patient weight up to a maximum of 60 ÎĽg |
|
| Placebo (physiological saline solution) | Placebo Comparator | Placebo (physiological saline solution) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alprostadil 20 micrograms | Drug | Intravenous infusion of PGE1 (Days 0, +1 and +2) |
|
| Measure | Description | Time Frame |
|---|---|---|
| determination of visual acuity | Test ETDRS (Early Treatment Diabetic Retinopathy Study) | Change from baseline visual acuity at 90 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Adverse Events | Adverse Event | Day 1, day +4,day+30 , day +90. |
| Intraocular Pressure | Intraocular Pressure | Day1,day+30 , day +90. |
Not provided
Inclusion criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rocio Hernandez Clares, MD | Contact | 968 369473. | rociohclares@hotmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClĂnico Universitario Virgen de la Arrixaca | Recruiting | Murcia | 30120 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Intravenous infusion of physiological saline solution |
|
| Visual Field | Humphrey Field Analyzer (HFA), | Day1,day+30 , day +90. |
| 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. |
| fundoscopic evaluation | Biomicroscopy | Day1,day+30 , day +90. |
| Hemodynamic indices of the ocular arteries | Doppler SIEMENS Antares™ System: | Day1,day+30 , day +90. |
| Optical disc area and cup / disc | Cirrus , Carl Zeiss Meditec, Dublin, California, ver: 6.0.2.81: | Day1,day+30 , day +90. |
| ID | Term |
|---|---|
| D018917 | Optic Neuropathy, Ischemic |
| ID | Term |
|---|---|
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided