The Effect of Dopamine on Diabetic Retinopathy

• Status: Completed
• Trial end date: 2019-08-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the use of electroretinogram (ERG) using a novel handheld system, RETeval, and evaluate contrast sensitivity testing in detecting pre-clinical retinopathy on a tablet device.

Investigators also seek to assess if a medication called Sinemet™ CR can improve the electrical functions of the eye in participants with diabetes mellitus. This study will include a total of 45 participants; 30 with diabetes mellitus and 15 age-matched non-diabetic controls. Participants with diabetes mellitus and electroretinogram (ERG) delays will be randomized to a low or high dose Sinemet CR group.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emory University
• Treatments: Carbidopa; Carbidopa, levodopa drug combination; Dopamine; Levodopa

Criteria

Inclusion Criteria

Participants with Diabetes Mellitus:

• Diagnosis of diabetes mellitus type-2

• HbA1c between 8 and 12%

Age-Matched Controls:

• Non-diabetic

Exclusion Criteria

Participants with Diabetes Mellitus:

• Currently taking dopamine-enhancing drugs (L-DOPA, bromocriptine)

• Currently taking nonselective monoamine oxidase (MAO) inhibitors

• Diagnosis of psychosis, Parkinson's disease, restless leg syndrome, major depression, confounding ocular disease (eg. visually significant cataract, glaucoma, macular degeneration, or retinitis pigmentosa)

• Pregnancy

Age-Matched Controls:

• Diabetes diagnosis

• Currently taking dopamine-enhancing drugs (L-DOPA, bromocriptine)

• Currently taking nonselective monoamine oxidase (MAO) inhibitors

• Diagnosis of psychosis, Parkinson's disease, restless leg syndrome, major depression, confounding ocular disease (eg. visually significant cataract, glaucoma, macular degeneration, or retinitis pigmentosa)

• Pregnancy