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

A Repeated Measures Study of Simvastatin on Choroideremia: Simvastatin Intervention and Reversal in Choroideremia Patients and Age-matched Controls.

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01654562

Enrollment

Registered

2012-07-31

Start date

2012-12-31

Completion date

2013-07-31

Last updated

2014-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choroideremia

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.

Interventions

DRUGSimvastatin

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Full-field scotopic threshold	5 weeks (4-6 weeks)	Full-field scotopic threshold measured at 4-6 weeks after simvastatin administration.

Secondary

Measure	Time frame	Description
Microperimetry, OCT, fundus autofluorescence, ERG, VA	5 weeks (4-6 weeks)	Correlation of retinal structure and function with changes in FST after administration of simvastatin.
Full-field scotopic threshold	5 weeks (4-6 weeks)	Full-field scotopic threshold after washout of simvastatin.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026