ENDOTHELION Study Group: Effect of Bosentan in NAION Patients

• Status: Unknown status
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Treatments: Bosentan

Criteria

Inclusion Criteria:

• Non arteritic ischemic optic neuropathy (NAION) with onset < 21 days with or without sleep apnea

• Negative pregnancy test and use of a effective conraceptive methode for non-menauposal wemen

• Signed informed consent

• Person affiliated to social security

• Patient with systolic pressure ≥ 100 mmHg

Exclusion Criteria:

• Pregnant, parturient or nursing woman

• Woman of child bearing potential without an effective contracptive method (use of hormonal contraception only is not considered effective)

• Other intercurrent ocular pathology, acute or chronic

• Simultaneaous bilateral NAION, ≤ 1 month

• Signs of another inflammatory neuropathy (Horton disease, optical nevritis, inflammatory optical neuropathy history)

• Signs of a retinal pathology

• Signs of a neuroretinis

• Patient with systolic pressure < 100 mmHg

• Patient with orthostatic hypotension

• Neurologic history : vascular or tumoral

• Systemic inflammatory pathology

• Known allergy to Bosentan

• Moderate to severe hepatic failure

• Glomerular filtration rate < 30 ml/min/1,73 m2

• Patient treated with drugs which efficacy can be lowered by CYP450, CYP2C9, CYP3A4 and CYP 2C19 activation

• Patient treated with amiodarone

• Patient treated with forbidden drugs for the study

• Patient treated with systemic corticotherapy

• Subject under juridic protection or not able to give informed consent, subject deprived of liberty

• Subject participaing to another clinical trial