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

NCT01654562 | Terminated Phase 1

• 1 other identifier: CHM-STATIN
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Choroideremia

Outcome Measures

Primary Outcomes (1)

• Full-field scotopic threshold

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

  5 weeks (4-6 weeks)

Secondary Outcomes (3)

• Microperimetry, OCT, fundus autofluorescence, ERG, VA

  5 weeks (4-6 weeks)

• Microperimetry, OCT, fundus autofluorescence, ERG, VA

  5 weeks (4-6 weeks)

• Full-field scotopic threshold

  5 weeks (4-6 weeks)

Study Arms (2)

CHM

EXPERIMENTAL

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

Age-matched controls

ACTIVE COMPARATOR

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

Interventions

Simvastatin DRUG

Simvastatin 40mg daily by mouth for 5 weeks (4-6 week window) followed by 5 week washout period (4-6 week window).

Also known as: Zocor

Age-matched controls; CHM

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Ophthalmology Research Office, University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location

MeSH Terms

Conditions

Choroideremia

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Choroid Diseases; Uveal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Ian M MacDonald, MD, CM

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2012
• First Posted: July 31, 2012
• Study Start: December 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 15, 2014

Record last verified: 2013-09

Locations

CA (1)