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| ID | Type | Description | Link |
|---|---|---|---|
| 2025P013031 | Other Identifier | Emory IRB |
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| Name | Class |
|---|---|
| Morningside Center for Innovative and Affordable Medicine | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Active Comparator | Diabetic participants will be instructed to take the oral placebo daily with a meal for 6 months. |
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| Levodopa every other day | Experimental | Diabetic participants will be instructed to take the levodopa every other day with a meal for 6 months. |
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| Levodopa once per day | Experimental | Diabetic participants will be instructed to take the oral levodopa daily with a meal for 6 months.. |
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| Levodopa twice per day | Experimental | Diabetic participants in the twice per day group will be instructed to take the drug 12 hours apart every day for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levodopa | Drug | Patients will receive tablets of generic 25 mg carbidopa/100 mg levodopa as the drug treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| ERG with dim flash stimuli | Full-field electroretinography (ERG) will be performed to assess rod-mediated retinal function. A skin electrode placed below the eye records the response to flash stimuli. Participants will be dark-adapted for 10 minutes to sensitive retinal rod pathways. Flash stimuli will consist of dim (1.13 Td) or bright (85 Td) flashes to reveal early dysfunction in DR. | Baseline, 3 and 6 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Optical coherence tomography (OCT) | Optical coherence tomography (OCT) will be done with the Heidelberg SLO+HRA to image the retina. The retinal vessels and retinal layers will be analyzed for any abnormalities. | Baseline, 3 and 6 months post-intervention |
| Optical coherence tomography (OCT-A) |
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Inclusion Criteria:
Exclusion Criteria:
Control Participants:
Non-diabetic participants with no visual problems to create control measurements.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Hendrick, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta VA Medical Center | Decatur | Georgia | 30033 | United States |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D007980 | Levodopa |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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Masking will be applied to diabetic participants.
| Placebo | Drug | Patients will receive matching placebo tablets as the drug treatment. |
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Optical coherence tomography (OCT) will be done with the Heidelberg SLO+HRA with an angiography module to image the retina. Percent of retinal area with perfusion abnormality will be calculated. |
| Baseline, 3 and 6 months post-intervention |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D002396 |
| Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |