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

• Register: EUCTR
• Last refreshed on: 18 September 2023
• Main ID: EUCTR2018-004072-35-FR
• Date of registration: 06/11/2018
• Prospective Registration: Yes
• Primary sponsor: CHU de Nice
• Public title: Study of the value of early treatment in patients with sudden blindness
• Scientific title: Study of the value of early treatment with an endothelin inhibitor (Bosentan) in patients with sudden blindness secondary to giant cell arteritis - CECIBO
• Date of first enrolment: 13/02/2019
• Target sample size: 8
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-004072-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

France

Contacts

• Name: DRCI
• Affiliation: CHU de Nice

• Name: DRCI
• Affiliation: CHU de Nice

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

giant cell arteritis
MedDRA version: 20.0 Level: PT Classification code 10003232 Term: Arteritis coronary System Organ Class: 10007541 - Cardiac disorders

Therapeutic area: Diseases [C] - Eye Diseases [C11]

Intervention(s)

Trade Name: BOSENTAN MYLAN
Product Name: BOSENTAN MYLAN
Pharmaceutical Form: Film-coated tablet

Primary Outcome(s)

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
2. improvement of visual field at 3 months
3. Evaluate the tolerance of the product in this indication

Timepoint(s) of evaluation of this end point: 3 months

Primary end point(s): Visual acuity measured according to the ETDRS scale at 3 months.

Secondary Outcome(s)

Secondary end point(s): 1. Visual acuity score measured according to the ETDRS scale at 1 month
2. Goldman unilateral visual field at 3 months
3. Evaluate Serious Adverse Events

Timepoint(s) of evaluation of this end point: One month and three month

Secondary ID(s)

18-AOIP-01

Source(s) of Monetary Support

CHU de Nice

Ethics review

Status: Approved
Approval date: 13/02/2019
Contact: