Optic ischaemic neuropathy Trials in Disease

Study on the Effects of Bosentan for Patients with Early Stage Non-Arteritic Anterior Ischemic Optic Neuropathy

This clinical trial is investigating whether bosentan, a medication typically used for pulmonary arterial hypertension, can help patients with early-stage non-arteritic anterior ischemic optic neuropathy. This condition occurs when reduced blood flow to the optic nerve causes sudden vision loss, typically affecting one eye. The condition often presents with painless, rapid vision loss that many patients notice upon waking.

Main inclusion criteria:

• Patients must be 50 years of age or older
• Must have a recent diagnosis of non-arteritic anterior ischemic optic neuropathy within 21 days, including visual field changes and swelling of the optic nerve head
• Systolic blood pressure must be 100 mmHg or higher
• Women of childbearing age must have a negative pregnancy test and use effective contraception
• Patients must be affiliated with a social security system
• Other conditions affecting the optic nerve, such as Horton's disease, must be ruled out

Main exclusion criteria:

• Presence of any other eye disease that could affect vision
• Eye surgery within the last 3 months
• History of severe heart problems
• Current use of medications that could interfere with the study drug
• Severe liver or kidney disease
• Pregnancy or breastfeeding
• Participation in another clinical trial within the last 30 days
• Known allergy to bosentan or similar medications

Focus and goals:

The primary goal of this trial is to evaluate whether bosentan can improve the visual field in patients with early-stage non-arteritic anterior ischemic optic neuropathy. The visual field refers to the entire area a person can see without moving their eyes. Participants will be randomly assigned to receive either bosentan or a placebo for comparison.

The study follows a structured approach over several months. After initial eligibility assessments, baseline measurements are taken, including visual field tests, optic nerve fiber layer thickness, and visual acuity. Participants then receive bosentan tablets at a dose of 250 mg daily for 2 months. The primary assessment occurs at 3 months, measuring the effect on visual field deficits. The study also tracks secondary outcomes including optic fiber layer thickness, visual clarity, inflammation markers, and blood pressure changes.

Long-term monitoring continues for up to 24 months to assess whether the condition affects the other eye and to evaluate overall quality of life. The trial is expected to run until December 2027.

Investigational drug:

Bosentan is administered orally as film-coated tablets. It works by blocking endothelin receptors, which helps relax blood vessels and improve blood flow. While it is already approved for treating pulmonary arterial hypertension, this trial is investigating whether these blood flow-improving properties can benefit the optic nerve and help preserve vision in patients with this acute condition.