Trial Summary
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.
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
Your eyes do not respond normally to low-intensity flashing lights.
I am diabetic and have tiny blood vessel changes in my eyes.
Your HbA1c levels are between 8% and 12%.
+1 more
Exclusion Criteria
Pregnancy
I haven't taken anti-VEGF or steroids in the past year.
You have trouble with memory and thinking, as measured by a test called the Montreal Cognitive Assessment (MOCA), scoring 24 or less.
+2 more
Participant Groups
The study tests if Sinemet CR (a form of levodopa) can slow down blood vessel changes in the eyes of diabetics compared to a placebo. Patients are chosen randomly to receive either the medication or a dummy pill.
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: SinemetExperimental Treatment1 Intervention
25 mg carbidopa/100 mg levodopa
Group II: follow-upActive Control1 Intervention
Follow-up testing on participants previously prescribed levodopa
Group III: PlaceboPlacebo Group1 Intervention
Placebo pill of similar size/shape
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Atlanta VA Medical and Rehab Center, Decatur, GADecatur, GA
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
Emory UniversityCollaborator