Back to resultsThe Short-term Effects of Simvastatin on the Vision of Males Affected by Choroideremia
Primary Purpose
Choroideremia
Status
Terminated
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Simvastatin
Sponsored by
About this trial
This is an interventional supportive care trial for Choroideremia
Eligibility Criteria
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
Sites / Locations
- Ophthalmology Research Office, University of Alberta
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CHM
Age-matched controls
Arm Description
Administration of 40mg simvastatin daily, orally for 5 weeks (4-6 weeks window), followed by 5 week (4-6 week window) washout period.
Administration of 40mg simvastatin daily, orally for 5 weeks (4-6 weeks window), followed by 5 week (4-6 week window) washout period.
Outcomes
Primary Outcome Measures
Full-field scotopic threshold
Full-field scotopic threshold measured at 4-6 weeks after simvastatin administration.
Secondary Outcome Measures
Microperimetry, OCT, fundus autofluorescence, ERG, VA
Correlation of retinal structure and function with changes in FST after administration of simvastatin.
Microperimetry, OCT, fundus autofluorescence, ERG, VA
Correlation of retinal structure and function with changes in FST after washout of simvastatin.
Full-field scotopic threshold
Full-field scotopic threshold after washout of simvastatin.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01654562
Brief Title
The Short-term Effects of Simvastatin on the Vision of Males Affected by Choroideremia
Official Title
A Repeated Measures Study of Simvastatin on Choroideremia: Simvastatin Intervention and Reversal in Choroideremia Patients and Age-matched Controls.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
The study has been terminated due to limited participant enrollment.
Study Start Date
December 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroideremia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CHM
Arm Type
Experimental
Arm Description
Administration of 40mg simvastatin daily, orally for 5 weeks (4-6 weeks window), followed by 5 week (4-6 week window) washout period.
Arm Title
Age-matched controls
Arm Type
Active Comparator
Arm Description
Administration of 40mg simvastatin daily, orally for 5 weeks (4-6 weeks window), followed by 5 week (4-6 week window) washout period.
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Other Intervention Name(s)
Zocor
Intervention Description
Simvastatin 40mg daily by mouth for 5 weeks (4-6 week window) followed by 5 week washout period (4-6 week window).
Primary Outcome Measure Information:
Title
Full-field scotopic threshold
Description
Full-field scotopic threshold measured at 4-6 weeks after simvastatin administration.
Time Frame
5 weeks (4-6 weeks)
Secondary Outcome Measure Information:
Title
Microperimetry, OCT, fundus autofluorescence, ERG, VA
Description
Correlation of retinal structure and function with changes in FST after administration of simvastatin.
Time Frame
5 weeks (4-6 weeks)
Title
Microperimetry, OCT, fundus autofluorescence, ERG, VA
Description
Correlation of retinal structure and function with changes in FST after washout of simvastatin.
Time Frame
5 weeks (4-6 weeks)
Title
Full-field scotopic threshold
Description
Full-field scotopic threshold after washout of simvastatin.
Time Frame
5 weeks (4-6 weeks)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian M MacDonald, MD, CM
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmology Research Office, University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2R3
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
The Short-term Effects of Simvastatin on the Vision of Males Affected by Choroideremia
We'll reach out to this number within 24 hrs