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

Phase 2TerminatedNCT01654562

University of Alberta2 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Choroideremia

Interventions

SimvastatinDRUG

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

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ophthalmology Research Office, University of Alberta

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

Full-field scotopic threshold

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

Time frame: 5 weeks (4-6 weeks)

Secondary Outcomes

Microperimetry, OCT, fundus autofluorescence, ERG, VA

Correlation of retinal structure and function with changes in FST after administration of simvastatin.

Time frame: 5 weeks (4-6 weeks)

Microperimetry, OCT, fundus autofluorescence, ERG, VA

Correlation of retinal structure and function with changes in FST after washout of simvastatin.

Time frame: 5 weeks (4-6 weeks)

Full-field scotopic threshold

Full-field scotopic threshold after washout of simvastatin.

Time frame: 5 weeks (4-6 weeks)

Data from ClinicalTrials.gov

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