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

Sponsor
University of Alberta (Other)
Overall Status
Terminated
CT.gov ID
NCT01654562
Collaborator
(none)
2
Enrollment
1
Location
2
Arms
7
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Repeated Measures Study of Simvastatin on Choroideremia: Simvastatin Intervention and Reversal in Choroideremia Patients and Age-matched Controls.
Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: CHM

Administration of 40mg simvastatin daily, orally for 5 weeks (4-6 weeks window), followed by 5 week (4-6 week window) washout period.

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

    		•
    Active Comparator: 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.

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Full-field scotopic threshold [5 weeks (4-6 weeks)]

      Full-field scotopic threshold measured at 4-6 weeks after simvastatin administration.

    Secondary Outcome Measures

    1. Microperimetry, OCT, fundus autofluorescence, ERG, VA [5 weeks (4-6 weeks)]

      Correlation of retinal structure and function with changes in FST after administration of simvastatin.

    2. 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.

    3. Full-field scotopic threshold [5 weeks (4-6 weeks)]

      Full-field scotopic threshold after washout of simvastatin.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ophthalmology Research Office, University of Alberta Edmonton Alberta Canada T6G 2R3

    Sponsors and Collaborators

    • University of Alberta

    Investigators

    • Principal Investigator: Ian M MacDonald, MD, CM, University of Alberta

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Alberta
    ClinicalTrials.gov Identifier:
    NCT01654562
    Other Study ID Numbers:
    • CHM-STATIN
    First Posted:
    Jul 31, 2012
    Last Update Posted:
    Oct 15, 2014
    Last Verified:
    Sep 1, 2013
    Additional relevant MeSH terms:
    Choroideremia
    Simvastatin

    Study Results

    No Results Posted as of Oct 15, 2014