Endothelin and Ischemic Optic Neuropathy study group

Phase 1

• Conditions: Endothelin and Ischemic Optic Neuropathy study group; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2014-000848-14-FR
• Lead Sponsor: Centre Hospitalier Universitaire de Grenoble

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-17
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Men(People) or women of more than 50 years,
Negative pregnancy test and use of an effective not hormonal contraception during all the duration of the study for the not menopausal women OR(WHERE) the menopause
Patients having signed the form of consent,
Patients affiliated to a national insurance scheme or a beneficiary of such a diet(regime).

The diagnosis of NOIAA is put in front of the recent appearance (lower in 21 days) a change of the field of vision, associated or not with a reduction in quickly progressive or rough painless visual acuteness and/or
AND associated with the clinical examination in an oedema papillaire diffuse or sectorial, of pale / white color, sometimes with péripapillaires bleedings.
The diagnosis of disease of Horton must be eliminated (cf page 22)
The diagnosis of a syndrome of apnea of the obstructive sleep (index of apneas-hypopnées = the 15 / hour of recording) is not essential for the randomization. Given that the not expanding(carrier) patients of a SAS(AIRLOCK,SIEVE) represent 15 % of the population studied NOIAA, an analysis a posteriori of these patients will be realized.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 43
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 43

Exclusion Criteria

Cannot be included the subjects answering in at least one of the following criteria:
Pregnant woman, parturiente or nursing mother
Women old enough to procreate using a hormonal alone contraception, about is its mode of administration.
Signs which can make suspect another inflammatory neuropathy: NOIAA artéritique (disease of Horton), pain during the mobilization of the globe or any sign which can evoke an optical névrite, a diagnosis known for SEP(MULTIPLE SCLEROSIS), history of inflammatory optical neuropathy (gay or ipsi-side). A biopsy of the temporal artery will be realized if symptoms evoking Horton, or pale and/or diffuse oedema, or franking(obliteration) of the central artery of the associated retina.
Signs which can evoke a retinal pathology,
Signs which can evoke a neuroretinitis or another optical neuropathy. Any atypie will require the realization of a brain imaging (MRI)

Patients reached(affected) by another eye pathology intercurrente acute(sharp) or chronic interfering on the visual acuteness or the field of vision (rétinopathie diabetic, medicinal or other, other optical neuropathy pressure of which close(plain) glaucoma or controlatéral and/or intraoculaire > 30 mmHg, cataract(waterfall) advance(overhang), corneal opacities, amblyopia 5/10, strong nearsightedness > 6 dioptres)
Simultaneous bilateral NOIAA, spaced out of 1 month or less

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified