2024-518345-21-00招募中3 期
Evaluation of the effects of bosentan in the management of patients in the acute phase of acute anterior ischemic optic neuropathy.
Centre Hospitalier Universitaire Grenoble Alpes4 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2024年10月30日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 94
- 试验地点
- 4
- 主要终点
- Average deficit (in decibels) in automated visual field 30/2
研究概览
简要总结
Evaluate at 3 MONTHS the effect on visual field (mean deficit) of bosentan 250 mg daily for 2 months (versus placebo) in early non-arteritic acute anterior ischemic optic neuropathy (NOIAA).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 50 or over
- •Negative pregnancy test and use of effective contraception for the duration of the study for non-menopausal women
- •Patients who have signed the consent form
- •Patients affiliated with or benefiting from a social security scheme
- •Patients with systolic blood pressure greater than or equal to 100 mmHg.
- •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
排除标准
- •Pregnant women, parturients and nursing mothers
- •Neurological history of vascular or tumoral origin that may alter the visual field or lead to optic neuropathy
- •Systemic inflammatory pathology
- •Known allergy to bosentan
- •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)
- •Estimated glomerular filtration rate (GFR) < 30 ml/min/1.73 m2
- •Patients treated with drugs whose efficacy may be reduced by activation of cytochrome P450, 2C9, 3A4 and 2C19 isoenzymes
- •Patients treated with cordarone® (amiodarone)
- •Patients treated with one of the treatments prohibited in the study (paragraph 5.5)
- •Patients treated with systemic corticosteroids (background treatment or treatment initiated at the time of NOIAA diagnosis)
- •Person deprived of liberty by judicial or administrative decision, legally protected adult, hospitalized person
- •Women of childbearing age using only hormonal contraception (including oral, injectable, implantable or trans-dermal contraceptives)
- •Ongoing participation in another clinical research study or exclusion period from another clinical study
- •Person under legal protection
- •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)
- •Simultaneous bilateral NOIAA, 1 month or less apart
- •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.
- •Signs suggestive of retinal pathology
- •Signs suggestive of neuroretinitis or other optic neuropathy. Any atypia will require brain imaging (MRI).
- •Patients with systolic blood pressure below 100 mmHg
- •Patients with orthostatic arterial hypotension (20 mmHg drop in SAP and/or 10 mmHg drop in DBP when moving to a standing position)
结局指标
主要结局
Average deficit (in decibels) in automated visual field 30/2
Average deficit (in decibels) in automated visual field 30/2
次要结局
- the thickness of the optic fiber layer in SD OCT of the affected eye
- visual acuity (ETDRS scale) and visual field parameters
- evaluation of the following inflammation biomarkers: RANTES, MCP-1, TNF-, INF-γ, IL-6, IL-10 and TGF
- daytime and nighttime blood pressure values and variations at Baseline
- automated visual field (mean deviation in Humphrey 30-2 and 60-4 sita-standard test, in dB) for healthy eye and NOIAA eye
- plasma assay for prepro-endothelin
- rate of bilateralization of the contralateral eye (occurrence of NOIAA) at 24 months
- quality of life questionnaire (French version of VFQ-25)
研究者
Christophe
Scientific
Centre Hospitalier Universitaire Grenoble Alpes
研究点 (4)
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