Evidence map›Paper›PMID 36309759›Full record

ArticleTrials2022

Treatment of nonarteritic anterior ischemic optic neuropathy with an endothelin antagonist: ENDOTHELION (ENDOTHELin antagonist receptor in Ischemic Optic Neuropathy)-a multicentre randomised controlled trial protocol.

Christophe Chiquet, Catherine Vignal, Philippe Gohier, Emmanuel Heron, Gilles Thuret, Marie Bénédicte Rougier, Audrey Lehmann, Laurent Flet, Jean-Louis Quesada, Mathieu Roustit and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02377271 (Effect of Bosentan in Patients With Non Arteritic Ischemic Optic Neuropathy), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.3field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02377271 phase3unknown statusnot on this map

Effect of Bosentan in Patients With Non Arteritic Ischemic Optic Neuropathy

TypeinterventionalSponsorUniversity Hospital, GrenobleRan2015 to 2025Enrolled86ConditionsIschemic Optic NeuropathyArmsbosentan, placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Dysregulation of histone deacetylases in ocular diseases.Archives of pharmacal research · 2024
    Review
  5. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 2 countries.

Christophe ChiquetDepartment of Ophthalmology, Grenoble Alpes University Hospital, 38043, Grenoble, France. christophe.chiquet@inserm.fr.ORCID http://orcid.org/0000-0002-7601-4885
Catherine VignalDepartment of Ophthalmology, Adolphe de Rothschild Foundation Hospital, 75940, Paris Cedex 19, France.
Philippe GohierDepartment of Ophthalmology, CHU de Angers, 49100, Angers, France.
Emmanuel HeronDepartment of Ophthalmology and Internal Medicine, Quinze-Vingts National Hospital Centre for Ophthalmology, 75940, Paris, France.
Gilles ThuretDepartment of Ophthalmology, CHU de Saint-Etienne, 42055, Saint-Etienne, France.
Marie Bénédicte RougierDepartment of Ophthalmology, Hôpital Pellegrin, CHU de Bordeaux, 33000, Bordeaux, France.
Audrey LehmannDepartment de Pharmacy, Grenoble-Alpes University Hospital, 38043, Grenoble, France.
Laurent FletDepartment of Pharmacy, PTMC -Clinical Trials, CHU de Nantes, 44000, Nantes, France.
Jean-Louis QuesadaClinical Pharmacology Unit, Grenoble Alpes University Hospital, Grenoble, France.
Mathieu RoustitHP2 Laboratory, INSERM U1300, Grenoble Alpes University, Grenoble, France.
Dan MileaVisual Neuroscience Group, Singapore Eye Research Institute (SERI), Singapore National Eye Institute (SNEC), Duke-NUS Graduate Medical School, Singapore, Singapore.
Jean-Louis PepinHP2 Laboratory, INSERM U1300, Grenoble Alpes University, Grenoble, France.
ENDOTHELION group
Inserm · FRCentre hospitalier national d'ophtalmologie des Quinze-Vingts · FRUniversité Grenoble Alpes · FRCentre Hospitalier Universitaire d'Angers · FRCentre Hospitalier Universitaire de Bordeaux · FRCentre Hospitalier Universitaire de Nantes · FRCentre Hospitalier Universitaire de Saint-Étienne · FRSingapore Eye Research Institute · SG

Funding

PHRC (FR) 2012Visio Foundation (FR) 2013
6 · The paper itself

Abstract

backgroundNonarteritic anterior ischemic optic neuropathy (NAAION) is a major cause of blindness in individuals over 50 years of age, with no available effective treatment. The oral dual endothelin receptor antagonist, bosentan, increases retinal optic nerve head blood flow in healthy humans and glaucoma patients. The objective of this trial is to assess the efficacy of bosentan administered at the acute stage in improving outcomes in NAAION patients.

methodsENDOTHELION (ENDOTHELin antagonist receptor in Ischemic Optic Neuropathy) is a phase III, interventional, prospective, multicentre, placebo-controlled randomised double-blind clinical trial. The primary outcome is change in the visual field mean deviation (MD) at 3 months (Humphrey 30-2 SITA standard programme). Secondary outcomes include MD and visual acuity changes up to 24 months, changes in peripapillary retinal nerve fibre and macular ganglion cell layer thickness in the affected eye, as measured by optical coherence tomography, rate of NAAION bilateralisation at 2 years, and quality-of-life. Patients over 50 years of age presenting with typical NAAION of recent onset (less than 21 days) are randomly assigned to either 125 mg oral bosentan or placebo, twice a day, during 8 weeks. Besides visits during the treatment phase, patients attend follow-up visits at 2, 3, 6, 12 and 24 months. The inclusion of patients began in August 2015 at five French University hospital ophthalmology departments and two specialised ophthalmology centres. It is planned to include 86 patients in this trial. To date we have included 72 patients and 49 have completed the full follow-up process. DISCUSSION: An endothelin receptor antagonist is a potential approach to improving the anatomical and functional prognosis of patients with NAAION. This multicentre double-blind randomised controlled trial is an opportunity to assess (1) the effect of bosentan on the structure and function of the optic nerve in NAAION, at 3 months, (2) the effect of bosentan on the bilateralisation rate at 24 months and (3) the tolerance profile of bosentan in this population.

trial registrationClinicalTrials.gov NCT02377271 . Registered on March 3, 2015.

Indexed as

Optic Neuropathy, IschemicBosentanClinical Trials, Phase III as TopicEndothelin Receptor AntagonistsHumansMiddle AgedMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicReceptors, EndothelinRetinal Ganglion CellsTomography, Optical CoherenceBosentanEndothelin Receptor AntagonistsReceptors, EndothelinBosentanEndothelinNonarteritic anterior ischaemic optic neuropathy (NAAION)Randomised controlled trialVisual field

Identifiers

PMID36309759
PMCPMC9617347
OpenAlexW4307951658

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.