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

Study of the value of early treatment with an endothelin inhibitor (Bosentan) in patients with sudden blindness secondary to giant cell arteritis - CECIBO

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004072-35-FR

Enrollment

Registered

2018-11-06

Start date

2019-02-13

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

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

Design outcomes

Secondary

Measure	Time frame
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	—

Primary

Measure	Time frame
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;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	—

Measure

Time frame

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;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

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Countries

France

Contacts

Public ContactDRCI

CHU de Nice

drc@chu-nice.fr04 92 03 40 11+33

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026