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

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ClinicalTrials.gov Identifier: NCT03851562
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

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).

Condition or disease Intervention/treatment Phase
Ischemic Optic Neuropathy Drug: Alprostadil 20 micrograms Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 13, 2018
Estimated Primary Completion Date : June 13, 2019
Estimated Study Completion Date : October 31, 2019


Arm Intervention/treatment
Experimental: Alprostadil 20 micrograms
1 μg / kg patient weight up to a maximum of 60 μg
Drug: Alprostadil 20 micrograms
Intravenous infusion of PGE1 (Days 0, +1 and +2)

Placebo Comparator: Placebo (physiological saline solution)
Placebo (physiological saline solution)
Drug: Placebo
Intravenous infusion of physiological saline solution




Primary Outcome Measures :
  1. determination of visual acuity [ Time Frame: Change from baseline visual acuity at 90 days. ]
    Test ETDRS (Early Treatment Diabetic Retinopathy Study)


Secondary Outcome Measures :
  1. Number of Serious Adverse Events [ Time Frame: Day 1, day +4,day+30 , day +90. ]
    Adverse Event

  2. Intraocular Pressure [ Time Frame: Day1,day+30 , day +90. ]
    Intraocular Pressure

  3. Visual Field [ Time Frame: Day1,day+30 , day +90. ]
    Humphrey Field Analyzer (HFA),

  4. Thickness of the layer of nerve fibers and ganglion cells in the retina [ Time Frame: Day1,day+30 , day +90. ]
    Cirrus , Carl Zeiss Meditec, Dublin, California, ver: 6.0.2.81:

  5. fundoscopic evaluation [ Time Frame: Day1,day+30 , day +90. ]
    Biomicroscopy

  6. Hemodynamic indices of the ocular arteries [ Time Frame: Day1,day+30 , day +90. ]
    Doppler SIEMENS Antares™ System:

  7. Optical disc area and cup / disc [ Time Frame: Day1,day+30 , day +90. ]
    Cirrus , Carl Zeiss Meditec, Dublin, California, ver: 6.0.2.81:



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03851562


Contacts
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Contact: Rocio Hernandez Clares, MD 968 369473. rociohclares@hotmail.com

Locations
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Spain
Hospital Clínico Universitario Virgen de la Arrixaca Recruiting
Murcia, Spain, 30120
Contact: Servicio de Neurología.    968369473      
Principal Investigator: Rocio Hernandez Clares, MD         
Sponsors and Collaborators
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

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Responsible Party: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
ClinicalTrials.gov Identifier: NCT03851562     History of Changes
Other Study ID Numbers: FFIS/PG/2017/03
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Ischemia
Optic Nerve Diseases
Optic Neuritis
Optic Neuropathy, Ischemic
Pathologic Processes
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Alprostadil
Vasodilator Agents
Urological Agents