Levodopa for Diabetic Retinopathy

Emory University230 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

230

Conditions

Diabetic Retinopathy

Interventions

LevodopaDRUG

Patients will receive tablets of generic 25 mg carbidopa/100 mg levodopa as the drug treatment.

PlaceboDRUG

Patients will receive matching placebo tablets as the drug treatment.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Adults * diagnosed with diabetes mellitus Exclusion Criteria: * taking dopamine effecting drugs * have a pituitary tumor * psychosis, Parkinson's disease * cognitive deficits * confounding ocular disease Control Participants: Non-diabetic participants with no visual problems to create control measurements.

Locations (1)

Atlanta VA Medical Center

Decatur, Georgia, United States

Outcomes

Primary Outcomes

ERG with dim flash stimuli

Full-field electroretinography (ERG) will be performed to assess rod-mediated retinal function. A skin electrode placed below the eye records the response to flash stimuli. Participants will be dark-adapted for 10 minutes to sensitive retinal rod pathways. Flash stimuli will consist of dim (1.13 Td) or bright (85 Td) flashes to reveal early dysfunction in DR.

Time frame: Baseline, 3 and 6 months post-intervention

Secondary Outcomes

Optical coherence tomography (OCT)

Optical coherence tomography (OCT) will be done with the Heidelberg SLO+HRA to image the retina. The retinal vessels and retinal layers will be analyzed for any abnormalities.

Time frame: Baseline, 3 and 6 months post-intervention

Optical coherence tomography (OCT-A)

Optical coherence tomography (OCT) will be done with the Heidelberg SLO+HRA with an angiography module to image the retina. Percent of retinal area with perfusion abnormality will be calculated.

Time frame: Baseline, 3 and 6 months post-intervention

Data from ClinicalTrials.gov

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