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

October 14, 2014 updated by: University of Alberta

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2R3
        • Ophthalmology Research Office, University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Full-field scotopic threshold
Time Frame: 5 weeks (4-6 weeks)
Full-field scotopic threshold measured at 4-6 weeks after simvastatin administration.
5 weeks (4-6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 weeks (4-6 weeks)
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.
5 weeks (4-6 weeks)
Full-field scotopic threshold
Time Frame: 5 weeks (4-6 weeks)
Full-field scotopic threshold after washout of simvastatin.
5 weeks (4-6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

July 27, 2012

First Submitted That Met QC Criteria

July 30, 2012

First Posted (ESTIMATE)

July 31, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 15, 2014

Last Update Submitted That Met QC Criteria

October 14, 2014

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHM-STATIN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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