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RHODOS Follow-up Single-visit Study (RHODOS-OFU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01421381
Recruitment Status : Completed
First Posted : August 22, 2011
Last Update Posted : May 27, 2013
Information provided by (Responsible Party):
Santhera Pharmaceuticals

Brief Summary:
This study aims to evaluate the current visual acuity of SNT-II-003 participants and compare this with the last visit from the SNT-II-003 study.

Condition or disease
Leber's Hereditary Optic Neuropathy

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Single Visit, Observational, Follow-up Study of Patients With Leber's Hereditary Optic Neuropathy Following Participation in SNT-II-003 Trial
Study Start Date : September 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2011

Primary Outcome Measures :
  1. logMAR visual acuity [ Time Frame: measure taken at the single study visit (Week 24) ]
    Change in best logMAR visual acuity (Best Acuity) compared to Visit 2/Baseline and Visit 5/Week 24 or last treatment visit of SNT-II-003

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 69 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who participated in study SNT-II-003

Inclusion Criteria:

  • Previous participation in study SNT-II-003

Information from the National Library of Medicine

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 identifier (NCT number): NCT01421381

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Canada, Quebec
Hôpital Notre-Dame (CHUM)
Montreal,, Quebec, Canada, H2L 4M1
Friedrich Baur Institut Neurologische Klinik und Poliklinik
München, Germany, D-80336
United Kingdom
Biomedical Research Centre, The Medical School
Newcastle upon Tyne, United Kingdom, NE2 4HH
Sponsors and Collaborators
Santhera Pharmaceuticals
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Principal Investigator: Patrick Chinnery, MD Clinical Research Facility

Publications of Results:
Other Publications:
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Responsible Party: Santhera Pharmaceuticals Identifier: NCT01421381    
Other Study ID Numbers: SNT-II-003-OFU
First Posted: August 22, 2011    Key Record Dates
Last Update Posted: May 27, 2013
Last Verified: May 2013
Keywords provided by Santhera Pharmaceuticals:
leber's hereditary optic neuropathy
Additional relevant MeSH terms:
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Optic Nerve Diseases
Optic Atrophy, Hereditary, Leber
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases
Optic Atrophies, Hereditary
Optic Atrophy
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Mitochondrial Diseases
Metabolic Diseases