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

University of Alberta

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Choroideremia

Treatments: Drug: Simvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01654562

CHM-STATIN

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

CHM

Experimental group

Description:

Administration of 40mg simvastatin daily, orally for 5 weeks (4-6 weeks window), followed by 5 week (4-6 week window) washout period.

Treatment:

Drug: Simvastatin

Age-matched controls

Active Comparator group

Description:

Administration of 40mg simvastatin daily, orally for 5 weeks (4-6 weeks window), followed by 5 week (4-6 week window) washout period.

Treatment:

Drug: Simvastatin