NCT02377271

ENDOTHELION Study Group: Effect of Bosentan in NAION Patients

Effect of Bosentan in Patients With Non Arteritic Ischemic Optic Neuropathy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Ischemic Optic Neuropathy

Interventions

Type	Name	Description
DRUG	bosentan	treatment by bosentan or placebo is randomized , 125 mg twice a day
DRUG	placebo	treatment by bosentan or placebo is randomized

Timeline

• Start date: 2015-08-01
• Primary completion: 2023-12-01
• Completion: 2025-12-01
• First posted: 2015-03-03
• Last updated: 2022-07-07

Locations

7 sites across 1 country: France