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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01654562
Recruitment Status : Terminated (The study has been terminated due to limited participant enrollment.)
First Posted : July 31, 2012
Last Update Posted : October 15, 2014
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Study Description
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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
Choroideremia Drug: Simvastatin Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : December 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

Arms and Interventions
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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 Name: 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 Name: Zocor


Outcome Measures
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Primary Outcome Measures :
  1. Full-field scotopic threshold [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 5 weeks (4-6 weeks) ]
    Correlation of retinal structure and function with changes in FST after washout of simvastatin.

  3. Full-field scotopic threshold [ Time Frame: 5 weeks (4-6 weeks) ]
    Full-field scotopic threshold after washout of simvastatin.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01654562


Locations
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Canada, Alberta
Ophthalmology Research Office, University of Alberta
Edmonton, Alberta, Canada, T6G 2R3
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Ian M MacDonald, MD, CM University of Alberta
More Information
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01654562    
Other Study ID Numbers: CHM-STATIN
First Posted: July 31, 2012    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: September 2013
Additional relevant MeSH terms:
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Choroideremia
Eye Diseases, Hereditary
Eye Diseases
Choroid Diseases
Uveal Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Simvastatin
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors