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Evaluation of the effects of bosentan in the management of patients in the acute phase of acute anterior ischemic optic neuropathy.
EU CTIS ID: 2024-518345-21-00
What this study is testing
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).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.