BOSENTAN for Non-arteritic anterior ischemic optic neuropathy (acute, early stage)

Inclusion criteria

• {"criterion_text":"- Men or women aged 50 or over\n- Negative pregnancy test and use of effective contraception for the duration of the study for non-menopausal women\n- Patients who have signed the consent form\n- Patients affiliated with or benefiting from a social security scheme\n- Patients with systolic blood pressure greater than or equal to 100 mmHg.\n- The diagnosis of NOIAA is made in the presence of recent onset (less than or equal to 21 days) of an alteration of the visual field, whether or not associated with a rapidly progressive or abrupt painless drop in visual acuity and/or, AND associated with diffuse or sectorial, pale/white papilledema, sometimes with peripapillary hemorrhages. the diagnosis of Horton's disease should be ruled out"}

Exclusion criteria

• {"criterion_text":"- Pregnant women, parturients and nursing mothers\n- Neurological history of vascular or tumoral origin that may alter the visual field or lead to optic neuropathy\n- Systemic inflammatory pathology\n- Known allergy to bosentan\n- Patients with moderate to severe hepatic impairment (Child-Pugh class B or C), biliary cirrhosis and cholestasis (serum levels of hepatic aminotransferases, aspartate aminotransferases (ASAT) and/or alanine aminotransferases (ALAT), greater than 3 times the upper limit of normal, bilirubin greater than 2 times normal)\n- Estimated glomerular filtration rate (GFR) < 30 ml/min/1.73 m2\n- Patients treated with drugs whose efficacy may be reduced by activation of cytochrome P450, 2C9, 3A4 and 2C19 isoenzymes\n- Patients treated with cordarone® (amiodarone)\n- - Patients treated with one of the treatments prohibited in the study (paragraph 5.5)\n- Patients treated with systemic corticosteroids (background treatment or treatment initiated at the time of NOIAA diagnosis)\n- Person deprived of liberty by judicial or administrative decision, legally protected adult, hospitalized person\n- Women of childbearing age using only hormonal contraception (including oral, injectable, implantable or trans-dermal contraceptives)\n- Ongoing participation in another clinical research study or exclusion period from another clinical study\n- Person under legal protection\n- Patients with other acute or chronic intercurrent ocular pathology interfering with visual acuity or visual field (diabetic, 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)\n- Simultaneous bilateral NOIAA, 1 month or less apart\n- Signs that may raise suspicion of another inflammatory neuropathy: arterial NOIAA (Horton's disease), pain on mobilization of the globe or any sign suggestive of optic neuritis, known diagnosis of MS, history of inflammatory optic neuropathy (homo or ipsi-lateral). A temporal artery biopsy will be performed in the presence of symptoms suggestive of Horton's disease, or in the presence of pale and/or diffuse edema, or associated obliteration of the central retinal artery.\n- Signs suggestive of retinal pathology\n- Signs suggestive of neuroretinitis or other optic neuropathy. Any atypia will require brain imaging (MRI).\n- Patients with systolic blood pressure below 100 mmHg\n- Patients with orthostatic arterial hypotension (20 mmHg drop in SAP and/or 10 mmHg drop in DBP when moving to a standing position)"}

Primary endpoints

• {"endpoint_text":"- Average deficit (in decibels) in automated visual field 30/2","definition_or_measurement_approach":"Automated visual field 30-2 (Humphrey 30-2 SITA-standard); mean deficit (mean deviation in decibels). Primary evaluation at 3 months comparing bosentan 250 mg daily for 2 months versus placebo."}

Secondary endpoints

• {"endpoint_text":"- the thickness of the optic fiber layer in SD OCT of the affected eye\n- visual acuity (ETDRS scale) and visual field parameters\n- evaluation of the following inflammation biomarkers: RANTES, MCP-1, TNF-, INF-γ, IL-6, IL-10 and TGF\n- daytime and nighttime blood pressure values and variations at Baseline\n- automated visual field (mean deviation in Humphrey 30-2 and 60-4 sita-standard test, in dB) for healthy eye and NOIAA eye\n- plasma assay for prepro-endothelin\n- rate of bilateralization of the contralateral eye (occurrence of NOIAA) at 24 months\n- quality of life questionnaire (French version of VFQ-25)","definition_or_measurement_approach":"SD-OCT measurement of retinal nerve fiber layer thickness in micrometers; visual acuity measured on ETDRS scale; visual field parameters via Humphrey automated perimetry (30-2 and 60-4 SITA-standard, mean deviation in dB); inflammatory biomarkers measured in plasma (RANTES, MCP-1, TNF-α, IFN-γ, IL-6, IL-10, TGF-β); daytime and nighttime systolic/diastolic blood pressure values and variations; plasma assay for prepro-endothelin; bilateralization rate assessed at 24 months; quality of life measured with French VFQ-25."}

France

Earliest CTIS Part Ii Submission Date

28-10-2024

Latest Decision Or Authorization Date

30-10-2024

Processing Time Days

2

Number Of Sites

4

Number Of Participants

94

Primary sponsor

Full Name

Centre Hospitalier Universitaire Grenoble Alpes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"PHRCI 2012 / Fondation Visio / APMC","duties_or_roles":"Monetary support (sourceOfMonetarySupport)","organisation_type":""}