AzTrials
AzTrials

Ischemic Optic NeuropathyPhase 3ENDOTHELIONNCT02377271

ENDOTHELION Study Group: Effect of Bosentan in NAION Patients

A Phase 3 study testing bosentan in people with Ischemic Optic Neuropathy, run by University Hospital, Grenoble at 7 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Acute ischemic optic neuropathy are the second leading cause of optic neuropathy after glaucoma in the population aged over 50 years. The visual prognosis of the condition is unfavorable in the great majority of cases, with significant effects on the visual field and vision. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Ischemic Optic Neuropathy
What is being tested?
bosentan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
7 sitesFrance
Study dates
Aug 2015to Feb 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Non arteritic ischemic optic neuropathy (NAION) with onset < 21 days
  • Age ≥ 50 years old
  • Signed informed consent form
  • Patients affiliated with a national health insurance scheme or beneficiaries of such a scheme

Who cannot join

  • Pregnant women, women in labour or breast-feeding mother
  • Patients with other acute or chronic intercurrent ocular pathology interfering with visual acuity or visual field (diabetes, drug-induced or other retinopathy, other optic neuropathy including uni- or contralateral glaucoma and/or intraocular pressure > 30 mmHg, advanced cataract, corneal opacities, amblyopia < 5/10, severe myopia > -6 diopters, retinal disease)
  • Simultaneous bilateral NAAION, 1 month apart or less
  • Signs that may raise suspicion of other inflammatory neuropathy: arterial NAAION (Horton's disease), pain on eye movement or any signs suggestive of optic neuritis, known diagnosis of multiple sclerosis, history of inflammatory optic neuropathy (homo- or ipsi-lateral). A temporal artery biopsy should be performed if there are symptoms suggestive of Horton's disease, or if there is pale and/or diffuse edema, or obliteration of the associated central retinal artery.
  • Patients with systolic blood pressure below 100 mmHg
  • Patient with orthostatic hypotension (20 mmHg drop in SBP and/or 10 mmHg drop in DBP when moving to a standing position)
Show all 16Show fewer
  • Neurological history of vascular or tumour-related changes to the visual field or other optic neuropathy
  • Systemic inflammatory disease
  • Known allergy to bosentan
  • Patients with moderate to severe hepatic impairment (Child-Pugh class B or C), biliary cirrhosis (serum levels of liver aminotransferases, aspartate aminotransferases (ASAT) and/or alanine aminotransferases (ALAT), greater than three times the upper limit of normal, bilirubin greater than twice normal)
  • Estimated glomerular filtration rate (GFR) < 30 ml/min/1.73 m2
  • Patients treated with drugs whose efficacy may be reduced by activation of cytochrome P450, 2C9, 3A4 and 2C19 isoenzymes
  • Patients treated with amiodarone
  • Patient treated with systemic corticosteroids (background treatment or treatment initiated at the time of NAAION diagnosis)
  • Person deprived of liberty by judicial or administrative decision, adult protected by law, hospitalized person
  • Ongoing participation in another clinical research study or in the exclusion period of another clinical study

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

France7 sites

  • University Hospital of Angers

    Angers, 49100

  • University Hospital of Bordeaux

    Bordeaux, 33000

  • CHU de Grenoble

    Grenoble, 38043

  • University Hospital of Grenoble Michallon

    Grenoble, 38043

  • Centre National d'Ophtalmologie XV-XX

    Paris, Paris

  • Ophtalmological fondation of Rothschild + Bichat Hospital

    Paris, 75019

  • University hospital of Saint-Etienne

    Saint-Etienne, 42055

Other trials in France

About this study

Official title: Effect of Bosentan in Patients With Non Arteritic Ischemic Optic Neuropathy

Acute ischemic optic neuropathy are the second leading cause of optic neuropathy after glaucoma in the population aged over 50 years. The visual prognosis of the condition is unfavorable in the great majority of cases, with significant effects on the visual field and vision. The severity of the unilateral condition is also associated with bilateralization in 15% at 5 years. There is no effective treatment for the acute phase of the disease or to reduce the rate of bilateralization. In this context, it is essential to develop new therapeutic strategies in the acute phase of the disease to reduce the anatomical optic nerve damage.

Read the detailed description

The main objective of our study will be to compare the treatment with bosentan to placebo for 8 weeks for recovery anatomical criteria (RFNL in OCT, optic atrophy) and functional (visual acuity, visual field). The primary endpoint will be the improvement of the visual field, a major criterion of the affected visual function in this disease.

The evaluation of bosentan will mainly after 8 weeks of treatment in order to assess the effectiveness of drug treatment in the absence of continuous positive airway pressure (set up after three months if necessary, feasible confounding factor for the evaluation of results ), the period of three months is sufficient to assess the anatomical and functional recovery (disappearance of papilledema).

Being tested
bosentan, placebo
Keywords
Bosentan
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.

  • bosentanDrug

    treatment by bosentan or placebo is randomized , 125 mg twice a day

  • placeboDrug

    treatment by bosentan or placebo is randomized

Study groups in NCT02377271
Study groupRoleWhat they receive
BosentanExperimentalBosentan at a dose of 125 mg two times daily, will be administered orally, twice a day, during eight weeks
Receives: Drug: bosentan
PlaceboPlacebo comparatorplacebo drug , twice a day, during eight weeks
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mean deviation of automated visual field

    Humphrey 30-2 SITA-standard

    Measured: 3 month

Secondary outcomes (7)

  1. visual acuity

    ETDRS scale

    Measured: 6, 12 and 24 month

  2. optic nerve fiber layer thickness

    OCT measurement

    Measured: 3, 6, 12 and 24 month

  3. mean deviation of automated visual field for healthy eye and NAION eye

    Humphrey 30-2

    Measured: 3, 6, 12 and 24 month

  4. inflammatory marker and prepro-endothelin dosing

    RANTES, MCP-1, TNF-α, INF-γ, IL-6, IL-10 and TGF-β

    Measured: 3 month

  5. mean deviation of automated visual field for controlateral eye

    Humphrey 30-2 sita-standard

    Measured: 24 month

  6. VFQ-25 score

    VFQ-25 quality of life

    Measured: 3 and 12 month

  7. rate of bilateral occurence of NAION

    rate of bilateralization

    Measured: at 24 month visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02377271
Sponsor's protocol ID
2014-000848-14
Other IDs
2014
Acronym
ENDOTHELION
Status last verified
Nov 2026
First submitted
5 Dec 2014
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Chiquet C, Vignal C, Gohier P, Heron E, Thuret G, Rougier MB, Lehmann A, Flet L, Quesada JL, Roustit M, Milea D, Pepin JL; ENDOTHELION group. Treatment of nonarteritic anterior ischemic optic neuropathy with an endothelin antagonist: ENDOTHELION (ENDOTHELin antagonist receptor in Ischemic Optic Neuropathy)-a multicentre randomised controlled trial protocol. Trials. 2022 Oct 29;23(1):916. doi: 10.1186/s13063-022-06786-9.

    PubMed 36309759

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bosentan in people with Ischemic Optic Neuropathy, run by University Hospital, Grenoble at 7 sites in France.

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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mean deviation of automated visual field (time frame: 3 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02377271, which also lists 1 linked publication.

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 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in