Choroideremia | The Short-term Effects of Simvastatin on the Vision of Males Affected by Choroideremia
Choroideremia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Participant is willing and able to give informed consent for participation in the study - Male - Diagnosed with choroideremia and in good health - Willing to allow his general practitioner and consultant, if appropriate, to be notified of participation in the study - Over age of 18 years Exclusion Criteria: - Female - Significant health disease, disorder, or medication, which, in the opinion of the investigator, would put the patient at risk if he were to take simvastatin - Already taking simvastatin or another statin
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:SimvastatinSimvastatin 40mg daily by mouth for 5 weeks (4-6 week window) followed by 5 week washout period (4-6 week window).
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
CHMAdministration of 40mg simvastatin daily, orally for 5 weeks (4-6 weeks window), followed by 5 week (4-6 week window) washout period.
Age-matched controlsAdministration of 40mg simvastatin daily, orally for 5 weeks (4-6 weeks window), followed by 5 week (4-6 week window) washout period.
Start Date: December 2012
Completed Date: July 2013
Phase: Phase 1/Phase 2
Primary Outcome: Full-field scotopic threshold
Secondary Outcome: Microperimetry, OCT, fundus autofluorescence, ERG, VA
Study sponsors, principal investigator, and references
Principal Investigator: Ian M MacDonald, MD, CM
Lead Sponsor: University of Alberta