The Effect of Dopamine on Diabetic Retinopathy (Dopamine DR)

Emory University

Status and phase: Completed; Phase 1

Conditions: Diabetes

Treatments: Drug: High Dose Sinemet CR; Other: Contrast Sensitivity Testing; Device: RETeval Electroretinogram (ERG) Testing; Drug: Low Dose Sinemet CR; Other: Visual Acuity Testing

Study type: Interventional

Funder types: Other

Identifiers

NCT02706977

IRB00083672

Details and patient eligibility

About

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.

Full description

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™ CT group.

Age-matched controls will not receive Sinemet Ct drug treatment.

The study involves four visits over the course of 4 weeks, each visit consisting of 2-3 hours. Visual testing will be performed at 1 day and 2 weeks following treatment. The drug treatment will be halted and testing repeated again after a 2 week wash-out period.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups

Diabetes Group - Low Dose Sinemet CR

Experimental group

Description:

Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive low dose Sinemet CR twice daily for two weeks.

Treatment:

Device: RETeval Electroretinogram (ERG) Testing

Other: Visual Acuity Testing

Drug: Low Dose Sinemet CR

Other: Contrast Sensitivity Testing

Diabetes Group - High Dose Sinemet CR

Experimental group

Description:

Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive high dose Sinemet CR twice daily for two weeks.

Treatment:

Device: RETeval Electroretinogram (ERG) Testing

Other: Visual Acuity Testing

Drug: High Dose Sinemet CR

Other: Contrast Sensitivity Testing

Diabetes Group - No Electroretinogram (ERG) Delays

Other group

Description:

Participants with diabetes mellitus type-2 who do not have electroretinogram (ERG) delays. Participants in this group will have one baseline visit only.

Treatment:

Device: RETeval Electroretinogram (ERG) Testing

Other: Visual Acuity Testing

Other: Contrast Sensitivity Testing

Age-Matched Controls

Other group

Description:

Participants will serve as age-matched controls for participants with diabetes. This group will participate in the baseline, week 2, and week 4 visits only.

Treatment:

Device: RETeval Electroretinogram (ERG) Testing

Other: Visual Acuity Testing

Other: Contrast Sensitivity Testing