Informations générales (source: ClinicalTrials.gov)
Effect of Bosentan in Patients With Non Arteritic Ischemic Optic Neuropathy (ENDOTHELION)
Interventional
Phase 3
University Hospital, Grenoble (Voir sur ClinicalTrials)
août 2015
décembre 2025
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FONDATION A. DE ROTHSCHILD | Catherine VIGNAL-CLERMONT | 21/06/2024 13:33:50 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHNO DES QUINZE-VINGTS PARIS | Catherine VIGNAL, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| University Hospital of Bordeaux - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| University hospital of Saint-Etienne - 42055 - Saint-Etienne - France | Philippe GAIN, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Grenoble - 38043 - Grenoble - France | Contact (sur clinicalTrials) | ||||
| Ophtalmological fondation of Rothschild + Bichat Hospital - 75019 - Paris - France | Catherine VIGNAL, MD | Contact (sur clinicalTrials) | |||
| University Hospital of Angers - 49100 - Angers - France | Philippe GOHIER, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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