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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
86
University Hospital of Angers
Angers, France
RECRUITINGUniversity Hospital of Bordeaux
Bordeaux, France
TERMINATEDCHU de Grenoble
Grenoble, France
RECRUITINGUniversity Hospital of Grenoble Michallon
Grenoble, France
RECRUITINGOphtalmological fondation of Rothschild + Bichat Hospital
Paris, France
RECRUITINGCentre National d'Ophtalmologie XV-XX
Paris, France
RECRUITINGUniversity hospital of Saint-Etienne
Saint-Etienne, France
RECRUITINGmean deviation of automated visual field
Humphrey 30-2 SITA-standard
Time frame: 3 month
visual acuity
ETDRS scale
Time frame: 6, 12 and 24 month
optic nerve fiber layer thickness
OCT measurement
Time frame: 3, 6, 12 and 24 month
mean deviation of automated visual field for healthy eye and NAION eye
Humphrey 30-2
Time frame: 3, 6, 12 and 24 month
inflammatory marker and prepro-endothelin dosing
RANTES, MCP-1, TNF-α, INF-γ, IL-6, IL-10 and TGF-β
Time frame: 3 month
mean deviation of automated visual field for controlateral eye
Humphrey 30-2 sita-standard
Time frame: 24 month
VFQ-25 score
VFQ-25 quality of life
Time frame: 3 and 12 month
rate of bilateral occurence of NAION
rate of bilateralization
Time frame: at 24 month visit
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