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

Choroideremia Clinical Trial

Official title:

A Repeated Measures Study of Simvastatin on Choroideremia: Simvastatin Intervention and Reversal in Choroideremia Patients and Age-matched Controls.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01654562
• Other study ID #: CHM-STATIN
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: July 27, 2012
• Last updated: October 14, 2014
• Start date: December 2012
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Choroideremia

Intervention

Drug:
• Simvastatin
Simvastatin 40mg daily by mouth for 5 weeks (4-6 week window) followed by 5 week washout period (4-6 week window).

Locations

Country	Name	City	State
Canada	Ophthalmology Research Office, University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Full-field scotopic threshold	Full-field scotopic threshold measured at 4-6 weeks after simvastatin administration.	5 weeks (4-6 weeks)	No
Secondary	Microperimetry, OCT, fundus autofluorescence, ERG, VA	Correlation of retinal structure and function with changes in FST after administration of simvastatin.	5 weeks (4-6 weeks)	No
Secondary	Microperimetry, OCT, fundus autofluorescence, ERG, VA	Correlation of retinal structure and function with changes in FST after washout of simvastatin.	5 weeks (4-6 weeks)	No
Secondary	Full-field scotopic threshold	Full-field scotopic threshold after washout of simvastatin.	5 weeks (4-6 weeks)	No