Clinical trial: Study of the Benefit of Early Treatment With an Endothelin Inhibitor (Bosentan) in Patients With Sudden Blindness Due to Giant Cell Arteritis: CECIBO (NCT03841734)

Eligibility criteria:
Inclusion Criteria:

          -  Decreased visual acuity (BVA) <5 days, regardless of degree of severity, abrupt onset
             in the context of newly diagnosed or suspected Horton's disease at this loss of visual
             acuity

          -  Able to sign the consent

          -  Affiliated to the social security system

          -  Already under conventional treatment of Horton's disease or the: requiring:
             Corticosteroids and + - anti-platelet aggregators and / or LMWH at the discretion of
             the referring physician for its vasculitis and + - immunosuppressive or biotherapy if
             necessary.

        Exclusion Criteria:

          -  Underlying hepatocellular insufficiency known

          -  Patient under guardianship or curator

          -  Hypersensitivity to the active substance or to any of the excipients

          -  Moderate to severe hepatic insufficiency corresponding to class B or C of the
             Child-Pugh classification

          -  Any other ophthalmological pathology explaining the sudden drop in vision: retinal
             detachment, retinal hemorrhage, posterior uveitis, nonarteritic arterial occlusion,
             cortical stroke

          -  Serum levels of hepatic aminotransferases, aspartate aminotransferases (ASTs) and / or
             alanine aminotransferases (ALATs), greater than 3 times the upper limit of normal
             before start of treatment

          -  Patient under treatment with cyclosporine A, antiretrovirals, glibenclamide or
             Rifampicin.

          -  Pregnant or lactating women
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.


Patient description (medical language): A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing.  He also complains of fatigue and hip muscle aches over the last several months.  The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications.  On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min.  Neurological examination is unremarkable.  Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation.

Patient description (patient's own words): I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage.

Does the patient match the trial criteria? Contradiction