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Phase 1 Pilot Study of 4-MP to Treat Stargardt Macular Dystrophy

Information source: University of Utah
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stargardt Macular Dystrophy

Intervention: 4-Methylpyrazole (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: University of Utah

Official(s) and/or principal investigator(s):
Paul S Bernstein, M.D., Ph.D., Principal Investigator, Affiliation: University of Utah

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.

Clinical Details

Official title: Clinical Interventions Against Stargardt Macular Dystrophy: Phase 1 Pilot Study of 4-MP as an Inhibitor of Dark Adaptation

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study

Primary outcome: Dark adaptation inhibition measured 30 minutes after drug infusion using Goldman-Weeker adaptometer.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- All nonpregnant, nonlactating adults with normal vision in both eyes

Exclusion Criteria:

- Previous ocular pathologies

Locations and Contacts

Moran Eye Center, University of Utah, Salt Lake City, Utah 84132, United States
Additional Information

Starting date: November 2005
Ending date: May 2006
Last updated: January 10, 2007

Page last updated: June 20, 2008

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