Levodopa for Diabetic Retinopathy
(TESDR Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have had anti-VEGF or steroid treatments in the last 12 months.
What data supports the effectiveness of the drug Levodopa for treating diabetic retinopathy?
Is levodopa safe for use in humans?
How does the drug Sinemet CR differ from other treatments for diabetic retinopathy?
Sinemet CR, which combines levodopa and carbidopa, is unique because it targets early retinal dysfunction in diabetic retinopathy by addressing dopamine deficiency, potentially reversing retinal damage before visible vascular changes occur. This approach is different from standard treatments that typically focus on managing visible symptoms of the disease.12589
What is the purpose of this trial?
To determine if levodopa will slow the appearance of blood vessel changes in the eyes of patients with diabetes. Treatment will be started in patients with diabetes show delays in the electrical activity of the retina when measured non-invasively with a electroretinogram.
Research Team
Machelle T. Pardue, PhD
Principal Investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
Eligibility Criteria
This trial is for diabetic patients without retinopathy or with minor blood vessel changes in the eyes, as confirmed by special imaging. They should have an HbA1c level between 8-12% and show specific delays on a retina test. It's not for those with certain brain diseases, cognitive issues, recent eye treatments, pregnancy, or other serious eye conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive levodopa or placebo twice daily for either 6 or 24 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebo
- Sinemet CR
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Emory University
Collaborator