244 Participants Needed

Levodopa for Diabetic Retinopathy

(TESDR Trial)

MT
Overseen ByMachelle T Pardue, PhD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: VA Office of Research and Development

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?

Research shows that Levodopa, when used with carbidopa, can improve vision in conditions like nonarteritic anterior ischemic optic neuropathy and indirect traumatic optic neuropathy, suggesting it might help with diabetic retinopathy too.12345

Is levodopa safe for use in humans?

The research articles provided do not contain specific safety data for levodopa, but it has been studied for other eye conditions, suggesting it is considered for human use.23467

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

MT

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

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%.
See 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.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive levodopa or placebo twice daily for either 6 or 24 months

6-24 months
Testing at baseline, every 3 months, and at 6, 12, and 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months
Follow-up testing on participants previously prescribed levodopa

Treatment Details

Interventions

  • Placebo
  • Sinemet CR
Trial Overview 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.
Participant Groups
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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Emory University

Collaborator

Trials
1,735
Recruited
2,605,000+

References

Levodopa-carbidopa and childhood retinal disease. [2019]
Levodopa as a possible treatment of visual loss in nonarteritic anterior ischemic optic neuropathy. [2018]
Levodopa may improve vision loss in recent-onset, nonarteritic anterior ischemic optic neuropathy. [2022]
Effect of levodopa and carbidopa on recovery of visual function in patients with nonarteritic anterior ischemic optic neuropathy of longer than six months' duration. [2019]
Levodopa-carbidopa may improve vision loss in indirect traumatic optic neuropathy. [2013]
The efficacy of somatostatin analogues in the treatment of diabetic retinopathy and thyroid eye disease. [2021]
Somatostatin in diabetic retinopathy. [2013]
Novel Detection and Restorative Levodopa Treatment for Preclinical Diabetic Retinopathy. [2020]
Initiation of L-DOPA Treatment After Detection of Diabetes-Induced Retinal Dysfunction Reverses Retinopathy and Provides Neuroprotection in Rats. [2022]
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