RHODOS Follow-up Single-visit Study
RHODOS-OFU
A Single Visit, Observational, Follow-up Study of Patients With Leber's Hereditary Optic Neuropathy Following Participation in SNT-II-003 Trial
1 other identifier
observational
60
3 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2011
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2011
CompletedFirst Posted
Study publicly available on registry
August 22, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMay 27, 2013
May 1, 2013
2 months
August 19, 2011
May 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
logMAR visual acuity
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)
Eligibility Criteria
Patients who participated in study SNT-II-003
You may qualify if:
- Previous participation in study SNT-II-003
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hôpital Notre-Dame (CHUM)
Montreal, Quebec, H2L 4M1, Canada
Friedrich Baur Institut Neurologische Klinik und Poliklinik
München, D-80336, Germany
Biomedical Research Centre, The Medical School
Newcastle upon Tyne, NE2 4HH, United Kingdom
Related Publications (2)
Klopstock T, Yu-Wai-Man P, Dimitriadis K, Rouleau J, Heck S, Bailie M, Atawan A, Chattopadhyay S, Schubert M, Garip A, Kernt M, Petraki D, Rummey C, Leinonen M, Metz G, Griffiths PG, Meier T, Chinnery PF. A randomized placebo-controlled trial of idebenone in Leber's hereditary optic neuropathy. Brain. 2011 Sep;134(Pt 9):2677-86. doi: 10.1093/brain/awr170. Epub 2011 Jul 25.
PMID: 21788663BACKGROUNDKlopstock T, Metz G, Yu-Wai-Man P, Buchner B, Gallenmuller C, Bailie M, Nwali N, Griffiths PG, von Livonius B, Reznicek L, Rouleau J, Coppard N, Meier T, Chinnery PF. Persistence of the treatment effect of idebenone in Leber's hereditary optic neuropathy. Brain. 2013 Feb;136(Pt 2):e230. doi: 10.1093/brain/aws279. Epub 2013 Feb 6. No abstract available.
PMID: 23388409RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Chinnery, MD
Clinical Research Facility
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2011
First Posted
August 22, 2011
Study Start
September 1, 2011
Primary Completion
November 1, 2011
Study Completion
December 1, 2011
Last Updated
May 27, 2013
Record last verified: 2013-05