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The study has been terminated due to limited participant enrollment.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug | Simvastatin 40mg daily by mouth for 5 weeks (4-6 week window) followed by 5 week washout period (4-6 week window). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Full-field scotopic threshold | Full-field scotopic threshold measured at 4-6 weeks after simvastatin administration. | 5 weeks (4-6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Microperimetry, OCT, fundus autofluorescence, ERG, VA | Correlation of retinal structure and function with changes in FST after administration of simvastatin. | 5 weeks (4-6 weeks) |
| Microperimetry, OCT, fundus autofluorescence, ERG, VA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian M MacDonald, MD, CM | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmology Research Office, University of Alberta | Edmonton | Alberta | T6G 2R3 | Canada |
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| ID | Term |
|---|---|
| D015794 | Choroideremia |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
Correlation of retinal structure and function with changes in FST after washout of simvastatin.
| 5 weeks (4-6 weeks) |
| Full-field scotopic threshold | Full-field scotopic threshold after washout of simvastatin. | 5 weeks (4-6 weeks) |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |