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

May 24, 2013 updated by: Santhera Pharmaceuticals

A Single Visit, Observational, Follow-up Study of Patients With Leber's Hereditary Optic Neuropathy Following Participation in SNT-II-003 Trial

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal,, Quebec, Canada, H2L 4M1
        • Hôpital Notre-Dame (CHUM)
  • Germany
      • München, Germany, D-80336
        • Friedrich Baur Institut Neurologische Klinik und Poliklinik
  • United Kingdom
      • Newcastle upon Tyne, United Kingdom, NE2 4HH
        • Biomedical Research Centre, The Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 69 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who participated in study SNT-II-003

Description

Inclusion Criteria:

  • Previous participation in study SNT-II-003

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
measure taken at the single study visit (Week 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santhera Pharmaceuticals

Investigators

  • Principal Investigator: Patrick Chinnery, MD, Clinical Research Facility

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 19, 2011

First Submitted That Met QC Criteria

August 19, 2011

First Posted (Estimate)

August 22, 2011

Study Record Updates

Last Update Posted (Estimate)

May 27, 2013

Last Update Submitted That Met QC Criteria

May 24, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNT-II-003-OFU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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