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The purpose of this study is to determine optimum dosing strategies of levodopa and determine the physiologic mechanisms that provide the therapeutic response to restore abnormalities in the electrical conductivity of the retina in people with diabetes and no clinically visible retinopathy.
This study is investigating the optimal timing of using levodopa in reducing damage in the retina from diabetes mellitus. Adult subjects will be recruited from the Atlanta VA Eye clinic and randomized to one of four arms: placebo, levodopa every other day, levodopa daily, or levodopa twice daily. Each group include participants that will receive treatment for 6 months with eye exams and testing conducted at baseline, 3 month, and 6 month visits. Testing at the visits includes electroretinograms, fundus photography, optical coherence tomography with angiography, and HbA1c serology. Veterans will sign the consent, in-person prior to beginning study activities.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Atlanta VA Medical Center
Decatur, Georgia, United States
Start Date
April 18, 2022
Primary Completion Date
November 17, 2025
Completion Date
November 17, 2025
Last Updated
March 3, 2026
230
ACTUAL participants
Levodopa
DRUG
Placebo
DRUG
Lead Sponsor
Emory University
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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