Trial of Cyclosporine in the Acute Phase of Leber Hereditary Optic Neuropathy (CICLO-NOHL)

University Hospital, Angers

Status and phase

Unknown

Phase 2

Conditions

Leber Hereditary Optic Neuropathy

Treatments

Drug: cyclosporine

Study type

Interventional

Funder types

Other

Identifiers

NCT02176733

PHRC 2010-05

Details and patient eligibility

About

The Leber Hereditary Optic Neuropathy is a genetic disorder caused by maternal transmission of mitochondrial DesoxiroboNucleid Acid mutations. It is manifested by a rapidly progressive blindness, profound, due to atrophic optic nerve. The visual loss is primarily unilateral bilateralisation taking place in the vast majority of cases in weeks or months. The neuro-cardio-protective properties of cyclosporine (and its analogs specifically targeting the anti-apoptotic mechanisms) are particularly promising.

The investigators hypothesis is that cyclosporine may limit apoptosis during the acute phase of the disease process and would limit the loss of visual acuity and improve the visual prognosis of these patients.

Enrollment

12 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patient with the mutation confirmed by molecular analysis
patient with a recent loss of monocular vision (≤ 6 months)
voluntarily Patient Consent

Exclusion criteria

patient who have not given their written and informed consent signed
against indication of cyclosporine
no drug compliance to previous inclusion
no national health insurance affiliation
pregnant women or lactating
women who could become pregnant during the study period and with no contraception
private patients of their liberty by judicial or administrative decision, or patients under supervision