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Dopamine Precursor

Levodopa for Diabetic Retinopathy (TESDR Trial)

Phase < 1
Waitlist Available
Led By Machelle T. Pardue, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diabetic patients with microaneurysms as detected with fundus teleretinal screening
Diabetic patients with no retinopathy as screened with teleretinal imaging
Must not have
No anti-VEGF or steroid treatments within the last 12 months
Patients with pituitary tumor, psychosis, Parkinson's disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months

Summary

This trial will test whether levodopa can slow the progression of diabetes-related changes in the retina.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not specified here, Sinemet CR may typically cause side effects like nausea, dizziness upon standing up quickly due to low blood pressure, involuntary movements (dyskinesia), and sleepiness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am diabetic and have tiny blood vessel changes in my eyes.
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I am diabetic and my eye screening showed no signs of retinopathy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken anti-VEGF or steroids in the past year.
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I have a pituitary tumor, psychosis, or Parkinson's disease.
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I do not have major eye diseases like cataract, glaucoma, or macular degeneration.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Electroretinogram
Secondary study objectives
Fundus photographs
HbA1c
Optical coherence tomography angiography

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sinemet CR
2011
Completed Phase 4
~70

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,658 Previous Clinical Trials
3,361,404 Total Patients Enrolled
Emory UniversityOTHER
1,696 Previous Clinical Trials
2,603,497 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
60 Patients Enrolled for Diabetic Retinopathy
Machelle T. Pardue, PhDPrincipal InvestigatorAtlanta VA Medical and Rehab Center, Decatur, GA

Media Library

Sinemet CR (Dopamine Precursor) Clinical Trial Eligibility Overview. Trial Name: NCT05132660 — Phase < 1
Diabetic Retinopathy Research Study Groups: follow-up, Sinemet, Placebo
Diabetic Retinopathy Clinical Trial 2023: Sinemet CR Highlights & Side Effects. Trial Name: NCT05132660 — Phase < 1
Sinemet CR (Dopamine Precursor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05132660 — Phase < 1
Diabetic Retinopathy Patient Testimony for trial: Trial Name: NCT05132660 — Phase < 1
~139 spots leftby Dec 2027
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