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ENDOTHELION Study Group: Effect of Bosentan in NAION Patients — ENDOTHELION  

Ischemic Optic Neuropathy Clinical Trial

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

Clinical 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. 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02377271
Study type Interventional
Source University Hospital, Grenoble
Contact Christophe Pr CHIQUET, Prof, MD, PhD
Email CChiquet@chu-grenoble.fr
Status Recruiting
Phase Phase 3
Start date August 2015
Completion date December 2025
View Details
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