The Short-term Effects of Simvastatin on the Vision of Males Affected by Choroideremia

Phase 1

Terminated

• Conditions: Choroideremia
• Interventions: Drug: Simvastatin

• Registration Number: NCT01654562
• Lead Sponsor: University of Alberta

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-27
• Study First Submitted QC: 2012-07-30
• Study First Posted: 2012-07-31
• Study Start: 2012-12
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-09
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CHM	Simvastatin	Administration of 40mg simvastatin daily, orally for 5 weeks (4-6 weeks window), followed by 5 week (4-6 week window) washout period.
Age-matched controls	Simvastatin	Administration of 40mg simvastatin daily, orally for 5 weeks (4-6 weeks window), followed by 5 week (4-6 week window) washout period.

Primary Outcome Measures

Name	Time	Method
Full-field scotopic threshold	5 weeks (4-6 weeks)	Full-field scotopic threshold measured at 4-6 weeks after simvastatin administration.

Secondary Outcome Measures

Name	Time	Method
Full-field scotopic threshold	5 weeks (4-6 weeks)	Full-field scotopic threshold after washout of simvastatin.
Microperimetry, OCT, fundus autofluorescence, ERG, VA	5 weeks (4-6 weeks)	Correlation of retinal structure and function with changes in FST after washout of simvastatin.

Trial Locations

Locations (1)

Ophthalmology Research Office, University of Alberta; 🇨🇦 Edmonton, Alberta, Canada