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OpenTrials
Completed

NCT Number: NCT00346853

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Moran Eye Center, University of Utah

Salt Lake City, Utah, 84132, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previous ocular pathologies

Treatment and study plan

4-Methylpyrazole

Drug

15 mg/kg dose

Saline

Other

Primary outcomes

  1. Dark adaptation inhibition measured 30 minutes after drug infusion using Goldman-Weeker adaptometer.

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jun 30, 2006
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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