Ischemic Optic NeuropathyPhase 2PG-NAIONNCT03851562
Intravenous Infusion of Prostaglandins as Therapy in Patients With Anterior Non-arteritic Ischemic Optic Neuropathy
A Phase 2 study testing Alprostadil 20 micrograms in people with Ischemic Optic Neuropathy, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Ischemic Optic Neuropathy
- What is being tested?
- Alprostadil 20 micrograms
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jun 2018to 31 Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120
Servicio de Neurología., 968369473
Rocio Hernandez Clares, MD
About this study
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
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).
- Conditions
- Ischemic Optic Neuropathy
- Being tested
- Alprostadil 20 micrograms, Placebo
- Medical subject headings
- Optic Neuropathy, Ischemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alprostadil 20 microgramsDrug
Intravenous infusion of PGE1 (Days 0, +1 and +2)
PlaceboDrug
Intravenous infusion of physiological saline solution
| Study group | Role | What they receive |
|---|---|---|
| Alprostadil 20 micrograms | Experimental | 1 μg / kg patient weight up to a maximum of 60 μg Receives: Drug: Alprostadil 20 micrograms |
| Placebo (physiological saline solution) | Placebo comparator | Placebo (physiological saline solution) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
determination of visual acuity
Test ETDRS (Early Treatment Diabetic Retinopathy Study)
Measured: Change from baseline visual acuity at 90 days.
Secondary outcomes (7)
Number of Serious Adverse Events
Adverse Event
Measured: Day 1, day +4,day+30 , day +90.
Intraocular Pressure
Intraocular Pressure
Measured: Day1,day+30 , day +90.
Visual Field
Humphrey Field Analyzer (HFA),
Measured: 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:
Measured: Day1,day+30 , day +90.
fundoscopic evaluation
Biomicroscopy
Measured: Day1,day+30 , day +90.
Hemodynamic indices of the ocular arteries
Doppler SIEMENS Antares™ System:
Measured: Day1,day+30 , day +90.
Optical disc area and cup / disc
Cirrus , Carl Zeiss Meditec, Dublin, California, ver: 6.0.2.81:
Measured: Day1,day+30 , day +90.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start13 Jun 2018
- Primary completion13 Jun 2019 (estimated)
- Study completion31 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Optic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851562
- Sponsor's protocol ID
- FFIS/PG/2017/03
- Acronym
- PG-NAION
- Status last verified
- Feb 2019
- First submitted
- 11 Jan 2019
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03851562
- Acronym / sponsor ID
- PG-NAION / FFIS/PG/2017/03
- Conditions
- Ischemic Optic Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 13 Jun 2019 (estimated)
- Study completion
- 31 Oct 2019 (estimated)
- First posted
- 22 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alprostadil 20 micrograms | Experimental | Drug: Alprostadil 20 micrograms1 μg / kg patient weight up to a maximum of 60 μg |
| Placebo (physiological saline solution) | Placebo comparator | Drug: PlaceboPlacebo (physiological saline solution) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alprostadil 20 microgramsIntravenous infusion of PGE1 (Days 0, +1 and +2) | Drug | Alprostadil 20 micrograms |
| PlaceboIntravenous infusion of physiological saline solution | Drug | Placebo (physiological saline solution) |
Primary outcome
determination of visual acuity
Time frame: Change from baseline visual acuity at 90 days.
Test ETDRS (Early Treatment Diabetic Retinopathy Study)
7 secondary outcomes
Number of Serious Adverse Events
Time frame: Day 1, day +4,day+30 , day +90.
Intraocular Pressure
Time frame: Day1,day+30 , day +90.
Visual Field
Time frame: Day1,day+30 , day +90.
Thickness of the layer of nerve fibers and ganglion cells in the retina
Time frame: Day1,day+30 , day +90.
fundoscopic evaluation
Time frame: Day1,day+30 , day +90.
Hemodynamic indices of the ocular arteries
Time frame: Day1,day+30 , day +90.
Optical disc area and cup / disc
Time frame: Day1,day+30 , day +90.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alprostadil 20 micrograms in people with Ischemic Optic Neuropathy, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rocio Hernandez Clares, MD (968 369473., rociohclares@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determination of visual acuity (time frame: Change from baseline visual acuity at 90 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2019.