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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Repeated Measures Study of Simvastatin on Choroideremia: Simvastatin Intervention and Reversal in Choroideremia Patients and Age-matched Con

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 Summary:
Sponsor: University of Alberta

Current Primary Outcome: Full-field scotopic threshold [ Time Frame: 5 weeks (4-6 weeks) ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University of Alberta

Dates:
Date Received: July 27, 2012
Date Started: December 2012
Date Completion:
Last Updated: October 14, 2014
Last Verified: September 2013