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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

Page last updated: August 23, 2015

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