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The purpose of this study is to investigate whether taking 4-methylpyrazole (4-MP, fomepizole, Antizolâ„¢) inhibits dark adaptation of the eye. In other words, we are testing if 4-MP slows the processing of vitamin A derivatives in the eye. By slowing down these processes, individuals with Stargardt disease may have better chances of saving their remaining vision. 4-MP has been shown to slow dark adaptation in animals, and is FDA approved for human use to treat individuals with methanol or ethylene glycol (antifreeze) poisoning by shutting down the body's ability to process alcohols. This medication has an excellent safety profile and has been reported to have no short-term or long-term side effects, as long as patients refrain from any alcohol while the medication is in the body. A single dose of 4-MP remains in the body for about 12 hours, and therefore, it may inhibit dark adaptation of your eyes for up to 12 hours. Studying the effects of 4-MP may lead to effective medical treatment to save Stargardt patients' vision, and may also have similar effects in other macular degenerative diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator | saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4-Methylpyrazole | Drug | 15 mg/kg dose |
| |
| saline |
| Measure | Description | Time Frame |
|---|---|---|
| Dark adaptation inhibition measured 30 minutes after drug infusion using Goldman-Weeker adaptometer. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul S Bernstein, M.D., Ph.D. | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moran Eye Center, University of Utah | Salt Lake City | Utah | 84132 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17963111 | Result | Jurgensmeier C, Bhosale P, Bernstein PS. Evaluation of 4-methylpyrazole as a potential therapeutic dark adaptation inhibitor. Curr Eye Res. 2007 Oct;32(10):911-5. doi: 10.1080/02713680701616156. |
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| ID | Term |
|---|---|
| D003317 | Corneal Dystrophies, Hereditary |
| D000080362 | Stargardt Disease |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
| D030342 | Genetic Diseases, Inborn |
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| ID | Term |
|---|---|
| D000077604 | Fomepizole |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Other |
|
| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |