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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014