ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Information source: University Hospital, Grenoble
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ischemic Optic Neuropathy
Intervention: bosentan (Drug); placebo (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: University Hospital, Grenoble Official(s) and/or principal investigator(s): Christophe Pr CHIQUET, Prof, MD, PhD, Principal Investigator, Affiliation: University Hospital, Grenoble
Overall contact: Christophe Pr CHIQUET, Prof, MD, PhD, Email: CChiquet@chu-grenoble.fr
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.
Clinical Details
Official title: Effect of Bosentan in Patients With Non Arteritic Ischemic Optic Neuropathy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: automated visual field (Humphrey 30-2 SITA-standard)
Secondary outcome: visual acuity (ETDRS scale)optic nerve fiber layer thickness
Detailed description:
The main objective of our study will be to compare the treatment with bosentan to placebo
for 8 weeks for recovery anatomical criteria (RFNL in OCT, optic atrophy) and functional
(visual acuity, visual field). The primary endpoint will be the improvement of the visual
field, a major criterion of the affected visual function in this disease.
The evaluation of bosentan will mainly after 8 weeks of treatment in order to assess the
effectiveness of drug treatment in the absence of continuous positive airway pressure (set
up after three months if necessary, feasible confounding factor for the evaluation of
results ), the period of three months is sufficient to assess the anatomical and functional
recovery (disappearance of papilledema).
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- non arteritic ischemic optic neuropathy (NAION) with onset < 21 days
Exclusion Criteria:
- pregnant woman
- other intercurrent ocular pathology
Locations and Contacts
Christophe Pr CHIQUET, Prof, MD, PhD, Email: CChiquet@chu-grenoble.fr
University Hospital of Angers, Angers 49100, France; Not yet recruiting Dan MILEA, MD, Phone: 0241353274, Email: dmilea@free.fr Stéphanie LERUEZ, MD, Sub-Investigator Frédéric GAGNADOUX, MD, Sub-Investigator Pascaline PRIOU, MD, Sub-Investigator
University Hospital of Bordeaux, Bordeaux 33000, France; Not yet recruiting Marie-Bénédicte ROUGIER, MD, Phone: 05 57 82 12 16, Email: marie-benedicte.rougier@chu-bordeaux.fr Jean-François KOROBELNIK, MD, Sub-Investigator Pierre PHILIP, MD, Sub-Investigator
CHU de Grenoble, Grenoble 38043, France; Not yet recruiting
University Hospital of Grenoble Michallon, Grenoble 38043, France; Not yet recruiting Christophe CHIQUET, MD, Phone: 04 76 76 55 16, Email: CChiquet@chu-grenoble.fr Florent APTEL, MD, Phone: 04 76 76 55 48, Email: faptel@chu-grenoble.fr Jean-Paul ROMANET, MD, Sub-Investigator Jean-Louis PEPIN, MD, Sub-Investigator Renaud TAMISIER, MD, Sub-Investigator Sandrine LAUNOIS-ROLLINAT, MD, Sub-Investigator Patrick LEVY, MD, Sub-Investigator Bertrand TOUSSAINT, MD, Sub-Investigator Olivier ORMEZZANO, MD, Sub-Investigator
University Hospital of Lyon, Lyon 69003, France; Not yet recruiting Carole BURILLON, MD, Phone: 0472116217, Email: carole.burillon@chu-lyon.fr Lucie ABOUAF, MD, Email: carole.burillon@chu-lyon.fr Frédéric GORMAND, MD, Sub-Investigator Sylvain BECCAT, MD, Sub-Investigator
Ophtalmological fondation of Rothschild + Bichat Hospital, Paris 75019, France
University hospital of Saint-Etienne, Saint-Etienne 42055, France; Not yet recruiting Philippe GAIN, MD, Phone: 0477127793, Email: philippe.gain@univ-st-etienne.fr Claire GUILLEMOT, MD, Phone: 0673169519, Email: claire.guillemot@gmail.com Gilles THURET, MD, Sub-Investigator Isabelle COURT-FORTUNE, MD, Sub-Investigator
Additional Information
Starting date: March 2015
Last updated: February 24, 2015
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