Clinical Trial: Historical Case Record Survey of Visual Acuity Data From Patients With Leber's Hereditary Optic Neuropathy (LHON)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Historical Case Record Survey of Visual Acuity Data From Patients With Leber's Hereditary Optic Neuropathy (LHON)

Brief Summary: The purpose of this survey is to collect visual acuity data from patients with LHON in order to establish the clinical course (natural history) and visual acuity outcomes in patients with a genetically confirmed diagnosis of LHON. In addition, this survey will generate data that will serve as comparator for the open-label study SNT-IV-006.

Detailed Summary:
Sponsor: Santhera Pharmaceuticals

Current Primary Outcome: Proportion of eyes with clinically relevant recovery or clinically relevant stabilization of VA [ Time Frame: 12 months ]

In eyes with a VA assessment made ≤1 year after the onset of symptoms: Proportion of eyes with clinically relevant recovery of VA from Baseline or in which Baseline VA better than 1.0 logarithm of the minimal angle of resolution (logMAR) was maintained at 12 months (primary time point)


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Santhera Pharmaceuticals

Dates:
Date Received: June 7, 2016
Date Started: May 2016
Date Completion:
Last Updated: March 1, 2017
Last Verified: March 2017