MedTrace Logo

ENDOTHELION Study Group: Effect of Bosentan in NAION Patients

NCT02377271 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2022-07-07

No results posted yet for this study

Summary

Acute ischemic optic neuropathy are the second leading cause of optic neuropathy after glaucoma in the population aged over 50 years. The visual prognosis of the condition is unfavorable in the great majority of cases, with significant effects on the visual field and vision. The severity of the unilateral condition is also associated with bilateralization in 15% at 5 years. There is no effective treatment for the acute phase of the disease or to reduce the rate of bilateralization. In this context, it is essential to develop new therapeutic strategies in the acute phase of the disease to reduce the anatomical optic nerve damage.

Conditions

  • Ischemic Optic Neuropathy

Interventions

DRUG

bosentan

treatment by bosentan or placebo is randomized , 125 mg twice a day

DRUG

placebo

treatment by bosentan or placebo is randomized

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Christophe Pr CHIQUET, Prof, MD, PhD · University Hospital, Grenoble

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2023-12-31
Completion
2025-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02377271 on ClinicalTrials.gov