early stage of acute non-arteritic anterior ischemic optic neuropathy
Conditions
Brief summary
Average deficit (in decibels) in automated visual field 30/2
Detailed description
the thickness of the optic fiber layer in SD OCT of the affected eye, visual acuity (ETDRS scale) and visual field parameters, evaluation of the following inflammation biomarkers: RANTES, MCP-1, TNF-, INF-γ, IL-6, IL-10 and TGF, daytime and nighttime blood pressure values and variations at Baseline, automated visual field (mean deviation in Humphrey 30-2 and 60-4 sita-standard test, in dB) for healthy eye and NOIAA eye, plasma assay for prepro-endothelin, rate of bilateralization of the contralateral eye (occurrence of NOIAA) at 24 months, quality of life questionnaire (French version of VFQ-25)
Interventions
DRUGBosentan/Mylan 125 mg επικαλυμμένα με λεπτό υμένιο δισκία
DRUGBosentan/Mylan 62
DRUG5 mg επικαλυμμένα με λεπτό υμένιο δισκία
Sponsors
Centre Hospitalier Universitaire Grenoble Alpes
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average deficit (in decibels) in automated visual field 30/2 | — |
Secondary
| Measure | Time frame |
|---|---|
| the thickness of the optic fiber layer in SD OCT of the affected eye, visual acuity (ETDRS scale) and visual field parameters, evaluation of the following inflammation biomarkers: RANTES, MCP-1, TNF-, INF-γ, IL-6, IL-10 and TGF, daytime and nighttime blood pressure values and variations at Baseline, automated visual field (mean deviation in Humphrey 30-2 and 60-4 sita-standard test, in dB) for healthy eye and NOIAA eye, plasma assay for prepro-endothelin, rate of bilateralization of the contralateral eye (occurrence of NOIAA) at 24 months, quality of life questionnaire (French version of VFQ-25) | — |
Countries
France
Outcome results
None listed