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

This study is not yet open for participant recruitment.
Verified November 2012 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01654562
First received: July 27, 2012
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Choroideremia
Drug: Simvastatin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Full-field scotopic threshold [ Time Frame: 5 weeks (4-6 weeks) ] [ Designated as safety issue: No ]
    Full-field scotopic threshold measured at 4-6 weeks after simvastatin administration.


Secondary Outcome Measures:
  • Microperimetry, OCT, fundus autofluorescence, ERG, VA [ Time Frame: 5 weeks (4-6 weeks) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Full-field scotopic threshold after washout of simvastatin.


Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01654562

Contacts
Contact: Paul Freund, MD pfreund@ualberta.ca

Locations
Canada, Alberta
Ophthalmology Research Office, University of Alberta Not yet recruiting
Edmonton, Alberta, Canada, T6G 2R3
Principal Investigator: Ian M MacDonald, MD         
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Ian M MacDonald, MD, CM University of Alberta
  More Information

No publications provided

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01654562     History of Changes
Other Study ID Numbers: CHM-STATIN
Study First Received: July 27, 2012
Last Updated: November 7, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Choroideremia
Eye Diseases, Hereditary
Eye Diseases
Choroid Diseases
Uveal Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Simvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014