Phase 1 Pilot Study of 4-MP to Treat Stargardt Macular Dystrophy
Completed · Phase 1
Conditions studied: Macular Dystrophy, Corneal
In brief
The purpose of this study is to investigate whether taking 4-methylpyrazole (4-MP, fomepizole, Antizol™) 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.
Key facts
- Study ID
- NCT00346853
- Run by
- University of Utah
- People needed
- 10
- Starts
- 2005-11-01
- Expected to finish
- 2006-09-01
- Last updated by the study team
- 2020-08-05
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- All nonpregnant, nonlactating adults with normal vision in both eyes
You may not qualify if…
- Previous ocular pathologies
Where it is running
- Moran Eye Center, University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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