Macular Dystrophy, Corneal
Conditions
Keywords
Dark adaptation inhibition, Stargardt macular dystrophy, 4-Methylpyrazole (4-MP), Antizol, Fomepizole
Brief summary
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.
Interventions
DRUG4-Methylpyrazole
15 mg/kg dose
OTHERsaline
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* All nonpregnant, nonlactating adults with normal vision in both eyes
Exclusion criteria
* Previous ocular pathologies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dark adaptation inhibition measured 30 minutes after drug infusion using Goldman-Weeker adaptometer. | 6 weeks |
Countries
United States
Outcome results
None listed