Clinical Trial: Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title:

Brief Summary:

The objective of this survey is to establish the clinical course of vision loss and recovery in patients with a genetically confirmed diagnosis of Leber Hereditary Optic Neuropathy (LHON).

Visual acuity changes over time from onset of symptoms and from visual acuity nadir will be the main endpoint analysed.

The survey will collect historically documented visual acuity data for all patients at participating sites with a genetically confirmed diagnosis of LHON. No exclusion criteria apply. Patients are not required to attend the clinic for the survey.

Data will be collected in a completely anonymous manner. Ethical approvals and data release agreements will be obtained as required by local regulations.


Detailed Summary:
Sponsor: Santhera Pharmaceuticals

Current Primary Outcome: Visual acuity [ Time Frame: average 0 to 10 years (retrospective) ]

The Entire duration of the disease patient by patient basis up to the date of completion of the Case Report Form (CRF).


Original Primary Outcome: Visual acuity [ Time Frame: average 0 to 10 years (retrospective) ]

The Entire duration of the disease patient by patient basis up to the date of completion of the CRF.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Santhera Pharmaceuticals

Dates:
Date Received: June 26, 2013
Date Started: August 2013
Date Completion:
Last Updated: May 14, 2014
Last Verified: May 2014