Trial of Cyclosporine in the Acute Phase of Leber Hereditary Optic Neuropathy (CICLO-NOHL)
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|ClinicalTrials.gov Identifier: NCT02176733|
Recruitment Status : Unknown
Verified January 2014 by University Hospital, Angers.
Recruitment status was: Recruiting
First Posted : June 27, 2014
Last Update Posted : June 27, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Leber Hereditary Optic Neuropathy||Drug: cyclosporine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||October 2015|
- Measurement of visual acuity with Monoyer, Early Treatment Diabetic Retinopathy Study and Parinaud scales [ Time Frame: at 9 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02176733
|Contact: D Mileafirstname.lastname@example.org|
|Centre Hospitalier Universitaire||Recruiting|
|Angers, France, 49000|
|Contact: D Milea email@example.com|