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ENDOTELION-undersøgelsesgruppe: Effekt af bosentan hos NAION-patienter (ENDOTHELION)

3. november 2026 opdateret af: University Hospital, Grenoble

Effekt af bosentan hos patienter med ikke-arteritisk iskæmisk optisk neuropati

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

86

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Angers, Frankrig, 49100
        • University Hospital of Angers
      • Bordeaux, Frankrig, 33000
        • University Hospital of Bordeaux
      • Grenoble, Frankrig, 38043
        • CHU de Grenoble
      • Grenoble, Frankrig, 38043
        • University Hospital of Grenoble Michallon
      • Paris, Frankrig, 75019
        • Ophtalmological fondation of Rothschild + Bichat Hospital
      • Saint-Etienne, Frankrig, 42055
        • University hospital of Saint-Etienne
    • Paris
      • Paris, Paris, Frankrig
        • Centre National d'Ophtalmologie XV-XX

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Bosentan

Bosentan at a dose of 125 mg two times daily, will be administered orally, twice a day, during eight weeks
Medicin: bosentan

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

placebo drug , twice a day, during eight weeks
Medicin: placebo

treatment by bosentan or placebo is randomized

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
mean deviation of automated visual field
Tidsramme: 3 month

Humphrey 30-2 SITA-standard
3 month

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
visual acuity
Tidsramme: 6, 12 and 24 month

ETDRS scale
6, 12 and 24 month
optic nerve fiber layer thickness
Tidsramme: 3, 6, 12 and 24 month

OCT measurement
3, 6, 12 and 24 month
mean deviation of automated visual field for healthy eye and NAION eye
Tidsramme: 3, 6, 12 and 24 month

Humphrey 30-2
3, 6, 12 and 24 month
inflammatory marker and prepro-endothelin dosing
Tidsramme: 3 month

RANTES, MCP-1, TNF-α, INF-γ, IL-6, IL-10 and TGF-β
3 month
mean deviation of automated visual field for controlateral eye
Tidsramme: 24 month

Humphrey 30-2 sita-standard
24 month
VFQ-25 score
Tidsramme: 3 and 12 month

VFQ-25 quality of life
3 and 12 month
rate of bilateral occurence of NAION
Tidsramme: at 24 month visit

rate of bilateralization
at 24 month visit

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Grenoble

Efterforskere

  • Ledende efterforsker: Christophe Pr CHIQUET, Prof, MD, PhD, University Hospital, Grenoble

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2015

Primær færdiggørelse (Anslået)

1. februar 2027

Studieafslutning (Anslået)

1. februar 2027

Datoer for studieregistrering

Først indsendt

5. december 2014

Først indsendt, der opfyldte QC-kriterier

24. februar 2015

Først opslået (Anslået)

3. marts 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2014-000848-14
  • 2014 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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