A Repeated Measures Study of Simvastatin on Choroideremia: Simvastatin Intervention and Reversal in Choroideremia Patients and Age-matched Controls.
Overview
- Phase
- Phase 1
- Intervention
- Simvastatin
- Conditions
- Choroideremia
- Sponsor
- University of Alberta
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Full-field scotopic threshold
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant is willing and able to give informed consent for participation in the study
- •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
- •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
Arms & Interventions
CHM
Administration of 40mg simvastatin daily, orally for 5 weeks (4-6 weeks window), followed by 5 week (4-6 week window) washout period.
Intervention: Simvastatin
Age-matched controls
Administration of 40mg simvastatin daily, orally for 5 weeks (4-6 weeks window), followed by 5 week (4-6 week window) washout period.
Intervention: Simvastatin
Outcomes
Primary Outcomes
Full-field scotopic threshold
Time Frame: 5 weeks (4-6 weeks)
Full-field scotopic threshold measured at 4-6 weeks after simvastatin administration.
Secondary Outcomes
- Full-field scotopic threshold(5 weeks (4-6 weeks))
- Microperimetry, OCT, fundus autofluorescence, ERG, VA(5 weeks (4-6 weeks))