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

Choroideremia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Choroideremia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Terminated

Start Date: December 2012

Completed Date: July 2013

Phase: Phase 1/Phase 2

Type: Interventional

Design:

Primary Outcome: Full-field scotopic threshold

Secondary Outcome: Microperimetry, OCT, fundus autofluorescence, ERG, VA

Study sponsors, principal investigator, and references

Principal Investigator: Ian M MacDonald, MD, CM

Lead Sponsor: University of Alberta

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01654562

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