Effect of Bosentan on Vision Recovery in NAION Patients
Effect of Bosentan in Patients With Non Arteritic Ischemic Optic Neuropathy
PHASE3 · University Hospital, Grenoble · NCT02377271
This study is testing if a medication called bosentan can help improve vision in older patients with recent non-arteritic ischemic optic neuropathy compared to a placebo.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University Hospital, Grenoble (other) |
| Locations | 7 sites (Angers and 6 other locations) |
| Trial ID | NCT02377271 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of bosentan compared to a placebo in patients with non-arteritic ischemic optic neuropathy (NAION) who have experienced symptoms for less than 21 days. Participants aged 50 and older will receive treatment for 8 weeks, during which their visual function and anatomical recovery will be assessed through various criteria, including visual acuity and visual field improvements. The study seeks to address the lack of effective treatments for this condition, which can lead to significant visual impairment and potential bilateralization. The primary endpoint focuses on the enhancement of the visual field, a critical aspect of visual function in NAION.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and older with a recent diagnosis of non-arteritic ischemic optic neuropathy.
Not a fit: Patients with other significant ocular pathologies or those with simultaneous bilateral NAION may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve visual recovery and quality of life for patients suffering from NAION.
How similar studies have performed: While there is limited data on the use of bosentan for this specific condition, similar studies exploring new treatments for optic neuropathies have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Non arteritic ischemic optic neuropathy (NAION) with onset \< 21 days * Age ≥ 50 years old * Signed informed consent form * Patients affiliated with a national health insurance scheme or beneficiaries of such a scheme Exclusion Criteria: * Pregnant women, women in labour or breast-feeding mother * Patients with other acute or chronic intercurrent ocular pathology interfering with visual acuity or visual field (diabetes, drug-induced or other retinopathy, other optic neuropathy including uni- or contralateral glaucoma and/or intraocular pressure \> 30 mmHg, advanced cataract, corneal opacities, amblyopia \< 5/10, severe myopia \> -6 diopters, retinal disease) * Simultaneous bilateral NAAION, 1 month apart or less * Signs that may raise suspicion of other inflammatory neuropathy: arterial NAAION (Horton's disease), pain on eye movement or any signs suggestive of optic neuritis, known diagnosis of multiple sclerosis, history of inflammatory optic neuropathy (homo- or ipsi-lateral). A temporal artery biopsy should be performed if there are symptoms suggestive of Horton's disease, or if there is pale and/or diffuse edema, or obliteration of the associated central retinal artery. * Patients with systolic blood pressure below 100 mmHg * Patient with orthostatic hypotension (20 mmHg drop in SBP and/or 10 mmHg drop in DBP when moving to a standing position) * Neurological history of vascular or tumour-related changes to the visual field or other optic neuropathy * Systemic inflammatory disease * Known allergy to bosentan * Patients with moderate to severe hepatic impairment (Child-Pugh class B or C), biliary cirrhosis (serum levels of liver aminotransferases, aspartate aminotransferases (ASAT) and/or alanine aminotransferases (ALAT), greater than three times the upper limit of normal, bilirubin greater than twice normal) * Estimated glomerular filtration rate (GFR) \< 30 ml/min/1.73 m2 * Patients treated with drugs whose efficacy may be reduced by activation of cytochrome P450, 2C9, 3A4 and 2C19 isoenzymes * Patients treated with amiodarone * Patient treated with systemic corticosteroids (background treatment or treatment initiated at the time of NAAION diagnosis) * Person deprived of liberty by judicial or administrative decision, adult protected by law, hospitalized person * Ongoing participation in another clinical research study or in the exclusion period of another clinical study
Where this trial is running
Angers and 6 other locations
- University Hospital of Angers — Angers, France (RECRUITING)
- University Hospital of Bordeaux — Bordeaux, France (TERMINATED)
- CHU de Grenoble — Grenoble, France (RECRUITING)
- University Hospital of Grenoble Michallon — Grenoble, France (RECRUITING)
- Ophtalmological fondation of Rothschild + Bichat Hospital — Paris, France (RECRUITING)
- Centre National d'Ophtalmologie XV-XX — Paris, France (RECRUITING)
- University hospital of Saint-Etienne — Saint-Etienne, France (RECRUITING)
Study contacts
- Principal investigator: Christophe Pr CHIQUET, Prof, MD, PhD — University Hospital, Grenoble
- Study coordinator: Christophe Pr CHIQUET, Prof, MD, PhD
- Email: CChiquet@chu-grenoble.fr
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ischemic Optic Neuropathy, Bosentan