A Phase 1/2 interventional study of Simvastatin in Choroideremia, sponsored by University of Alberta. Terminated at 1 site in Canada. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-15.
Sponsored by University of Alberta · Phase 1/2, Interventional, and Supportive care
Primary objective: To examine the short-term effects of of simvastatin on the vision on males with choroideremia, evaluated by full-field scotopic threshold testing. The investigators hypothesize that they will see a reversible decrease in the dark-adapted vision in participants taking simvastatin.
29 studies on the registry are indexed under Choroideremia; 6 are open to participants now.
This study's enrollment of 2 is below the median of 14 across 19 interventional studies indexed under Choroideremia.
Browse Choroideremia studies →University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Administration of 40mg simvastatin daily, orally for 5 weeks (4-6 weeks window), followed by 5 week (4-6 week window) washout period.
Drug: Simvastatin
Administration of 40mg simvastatin daily, orally for 5 weeks (4-6 weeks window), followed by 5 week (4-6 week window) washout period.
Drug: Simvastatin
Simvastatin 40mg daily by mouth for 5 weeks (4-6 week window) followed by 5 week washout period (4-6 week window).
Also known as: Zocor
Full-field scotopic threshold
Full-field scotopic threshold measured at 4-6 weeks after simvastatin administration.
Time frame: 5 weeks (4-6 weeks)
Microperimetry, OCT, fundus autofluorescence, ERG, VA
Correlation of retinal structure and function with changes in FST after administration of simvastatin.
Time frame: 5 weeks (4-6 weeks)
Microperimetry, OCT, fundus autofluorescence, ERG, VA
Correlation of retinal structure and function with changes in FST after washout of simvastatin.
Time frame: 5 weeks (4-6 weeks)
Full-field scotopic threshold
Full-field scotopic threshold after washout of simvastatin.
Time frame: 5 weeks (4-6 weeks)
This study is terminated, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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University of Alberta