NCT07444892

Levodopa for Diabetic Retinopathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	Levodopa	Patients will receive tablets of generic 25 mg carbidopa/100 mg levodopa as the drug treatment.
DRUG	Placebo	Patients will receive matching placebo tablets as the drug treatment.

Timeline

• Start date: 2022-04-18
• Primary completion: 2025-11-17
• Completion: 2025-11-17
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study