Study of the value of early treatment in patients with sudden blindness

Phase 1

• Conditions: giant cell arteritis; MedDRA version: 20.0Level: PTClassification code 10003232Term: Arteritis coronarySystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2018-004072-35-FR
• Lead Sponsor: CHU de Nice

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-06
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Age > 50 years old
• Decreased visual acuity (BVA), regardless of degree of severity, sudden onset in the context of newly diagnosed or suspected Horton's disease
• Diagnostic BAV <58 days
• Conventional treatment of Horton's disease: Corticosteroids and + - anti-platelet aggregators and / or LMWH at the discretion of the referring physician for his vascularity and + - immunosuppressive or biologic pathology if necessary.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

• BAV and ischemia over 5 days
• Underlying hepatocellular insufficiency known
• Patient under guardianship or curatorship
• 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
• 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 on cyclosporine A therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effects of bosentan (endothelin inhibitor), in combination with conventional therapy, in patients with a sudden decrease in visual acuity, either uni or bilaterally, in the acute phase of giant cell arteritis (Horton's disease) , on recovery of visual acuity at 3 months.;Secondary Objective: 1. improvement of visual acuity from the first month<br>2. improvement of visual field at 3 months<br>3. Evaluate the tolerance of the product in this indication;Primary end point(s): Visual acuity measured according to the ETDRS scale at 3 months.;Timepoint(s) of evaluation of this end point: 3 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Visual acuity score measured according to the ETDRS scale at 1 month<br>2. Goldman unilateral visual field at 3 months<br>3. Evaluate Serious Adverse Events;Timepoint(s) of evaluation of this end point: One month and three month