NCT03851562

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

1 year

First QC Date

January 11, 2019

Last Update Submit

February 22, 2019

Conditions

Ischemic Optic Neuropathy

Outcome Measures

Primary Outcomes (1)

  • determination of visual acuity

    Test ETDRS (Early Treatment Diabetic Retinopathy Study)

    Change from baseline visual acuity at 90 days.

Secondary Outcomes (7)

  • Number of Serious Adverse Events

    Day 1, day +4,day+30 , day +90.

  • Intraocular Pressure

    Day1,day+30 , day +90.

  • Visual Field

    Day1,day+30 , day +90.

  • Thickness of the layer of nerve fibers and ganglion cells in the retina

    Day1,day+30 , day +90.

  • fundoscopic evaluation

    Day1,day+30 , day +90.

  • +2 more secondary outcomes

Study Arms (2)

Alprostadil 20 micrograms

EXPERIMENTAL

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

Drug: Alprostadil 20 micrograms

Placebo (physiological saline solution)

PLACEBO COMPARATOR

Placebo (physiological saline solution)

Drug: Placebo

Interventions

Alprostadil 20 microgramsDRUG

Intravenous infusion of PGE1 (Days 0, +1 and +2)

Alprostadil 20 micrograms
PlaceboDRUG

Intravenous infusion of physiological saline solution

Placebo (physiological saline solution)

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

RECRUITING

MeSH Terms

Conditions

Optic Neuropathy, Ischemic

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Rocio Hernandez Clares, MD

CONTACT

968 369473.rociohclares@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2019

First Posted

February 22, 2019

Study Start

June 13, 2018

Primary Completion

June 13, 2019

Study Completion

October 31, 2019

Last Updated

February 25, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)