Santhera CRS
Research type
Research Study
Full title
Historical Case Record Survey of Visual Acuity Data from Patients with Leber's Hereditary Optic Neuropathy (LHON) SNT-CRS-002
IRAS ID
195281
Contact name
Marcela Votruba
Contact email
Sponsor organisation
Santhera Pharmaceutical (Switzerland) Ltd
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
A multi-country, multi-centre, historical case record survey which will
collect data on the VA of eligible patients from existing medical records.
Data will be collected from as many case records as possible during
the case record survey collection period. A minimum of 89 eligible
patients with onset of symptoms ≤1 year prior to Baseline is required
for sufficient statistical power for comparison to perform the cross
analysis with SNT-IV-005 (Santhera Open Label Study)study.
CRS data will be collected from expert clinical study sites that maintain records of VA assessments for LHON patients that may participate in the SNT-IV-005 study, the Post Authorisation Safety Study (PASS; SNT-IV-003) and from other clinical sites.
Patients who provide(d) VA data for this CRS (SNT-CRS-002 and eligible patients from SNTIR-006) will not be eligible for enrolment in SNT-IV-005 to ensure that the CRS data is independent of SNT-IV-005.
Data will be collected in a completely anonymous manner. Ethical approvals and data release agreements will be obtained as required by local regulations. Each eligible LHON patient with historical data at each site will be given a sequential unique identifying number. If a signed data release agreement is not in place and the patient cannot be contacted or if the patient refuses to sign the data release form, the site will not collect data of the patient for the study.
As this is a non-interventional historical case record survey study, the study will not provide or recommend any treatment and will not influence the physician’s drug prescription or therapy choices or other management of the patient’s disease.REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0184
Date of REC Opinion
6 Jul 2016
REC opinion
Further Information Favourable Opinion