The Effect of Dopamine on Diabetic Retinopathy

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.

Conditions

• Diabetes

Interventions

DRUG

Low Dose Sinemet CR

Sinemet CR (25 mg carbidopa/100 mg levodopa) will be taken by mouth twice daily for two weeks.

DRUG

High Dose Sinemet CR

Sinemet CR (50 mg carbidopa/200 mg levodopa) will be taken by mouth twice daily for two weeks.

DEVICE

RETeval Electroretinogram (ERG) Testing

ERG testing consists of sitting in the dark for 15 minutes. During the procedure, participants will have a single-use adhesive sensor strip placed on the skin near the eye. A hand-held device, called the RETeval, will be placed in front of the eye and a series of flashes and flickering lights presented. The light intensity level is typically not uncomfortable. When right eye imaging is complete, the procedure will be repeated on the left eye. Both eyes will be evaluated in less than 5 minutes for most participants. Electroretinogram (ERG) testing will be completed at baseline, day 1, week 2, and week 4.

OTHER

Contrast Sensitivity Testing

Contrast sensitivity testing consists of looking at a series of moving lines on a tablet device. The lines will change from white to grey to black. Participants will be asked to determine when they can no longer distinguish between the lines. Contrast sensitivity testing will be completed at baseline, day 1, week 2, and week 4.

OTHER

Visual Acuity Testing

Participants will be asked to look at an eye chart with letters or symbols that become smaller as they move from top to bottom of the chart. Visual acuity testing will be completed at baseline, day 1, week 2, and week 4.

Sponsors & Collaborators

• Emory University

  lead OTHER

Principal Investigators

• Machelle Pardue, PhD · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2019-08-15

Completion

2019-08-15

Countries

• United States

Study Locations