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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00346853 |
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Date of registration:
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28/06/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase 1 Pilot Study of 4-MP to Treat Stargardt Macular Dystrophy
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Scientific title:
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Clinical Interventions Against Stargardt Macular Dystrophy: Phase 1 Pilot Study of 4-MP as an Inhibitor of Dark Adaptation |
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Date of first enrolment:
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November 2005 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00346853 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Paul S Bernstein, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Utah |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All nonpregnant, nonlactating adults with normal vision in both eyes
Exclusion Criteria:
- Previous ocular pathologies
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Macular Dystrophy, Corneal
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Intervention(s)
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Other: saline
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Drug: 4-Methylpyrazole
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Primary Outcome(s)
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Dark adaptation inhibition measured 30 minutes after drug infusion using Goldman-Weeker adaptometer.
[Time Frame: 6 weeks]
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Secondary ID(s)
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4-MP Dark Adaptation Inhib.
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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