The Effect of Dopamine on Diabetic Retinopathy

Phase 1

Completed

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

• Registration Number: NCT02706977
• Lead Sponsor: Emory University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-03-04
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-11
• Primary Completion: 2019-08-15
• Study Completion: 2019-08-15
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-07
• Last Update Posted: 2019-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetes Group - Low Dose Sinemet CR	Low Dose Sinemet CR	Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive low dose Sinemet CR twice daily for two weeks.
Diabetes Group - Low Dose Sinemet CR	RETeval Electroretinogram (ERG) Testing	Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive low dose Sinemet CR twice daily for two weeks.
Diabetes Group - Low Dose Sinemet CR	Contrast Sensitivity Testing	Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive low dose Sinemet CR twice daily for two weeks.
Diabetes Group - High Dose Sinemet CR	High Dose Sinemet CR	Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive high dose Sinemet CR twice daily for two weeks.
Diabetes Group - High Dose Sinemet CR	RETeval Electroretinogram (ERG) Testing	Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive high dose Sinemet CR twice daily for two weeks.
Diabetes Group - High Dose Sinemet CR	Contrast Sensitivity Testing	Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive high dose Sinemet CR twice daily for two weeks.
Diabetes Group - High Dose Sinemet CR	Visual Acuity Testing	Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive high dose Sinemet CR twice daily for two weeks.
Diabetes Group - Low Dose Sinemet CR	Visual Acuity Testing	Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive low dose Sinemet CR twice daily for two weeks.
Diabetes Group - No Electroretinogram (ERG) Delays	RETeval Electroretinogram (ERG) Testing	Participants with diabetes mellitus type-2 who do not have electroretinogram (ERG) delays. Participants in this group will have one baseline visit only.
Diabetes Group - No Electroretinogram (ERG) Delays	Contrast Sensitivity Testing	Participants with diabetes mellitus type-2 who do not have electroretinogram (ERG) delays. Participants in this group will have one baseline visit only.
Diabetes Group - No Electroretinogram (ERG) Delays	Visual Acuity Testing	Participants with diabetes mellitus type-2 who do not have electroretinogram (ERG) delays. Participants in this group will have one baseline visit only.
Age-Matched Controls	Contrast Sensitivity Testing	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.
Age-Matched Controls	Visual Acuity Testing	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.
Age-Matched Controls	RETeval Electroretinogram (ERG) Testing	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.

Primary Outcome Measures

Name	Time	Method
Change in Contrast Sensitivity assessed by the Contrast Sensitivity Function v1.0 (CSF v1.0) Tablet Application	Baseline, Week 4	Participants will view the screen monocularly while wearing their normal correction. A drifting grating will be presented at 60 cm for 3, 6, 12 and 18 c/d. Following photopic testing (100 lux), the participant will be dark-adapted and a neutral density filter will be applied to the tablet screen to produce luminance of \~1 lux.
Change in Retinal Function assessed by Electroretinogram (ERG) Device	Baseline, Week 4	The RETeval device consists of a hand-held wand with a pupil tracker. A skin electrode placed below the eye or DTL fiber records the response to flash stimuli. The pupil tracker provides feedback to the system so that the flash stimuli can compensate for the pupil size and produce the proper illumination to the retina. RETeval is intended to generate photopic signals and measure and display the electrical response signals generated by the retina and the visual nervous system using flash stimuli.
Change in Contrast Sensitivity assessed by the Sine Wave Grafting Test (CSV-1000E)	Baseline, Week 4	The CSV-1000E is self-illuminated (85 cd/m2). A drifting grating will be presented at 60 cm for 3, 6, 12 and 18 c/d. The participant will view the chart from 2.5m. The intensity of the CSV-1000 will be reduced to 1 lux with neutral density filters for scotopic testing.
Change in Visual Acuity assessed by the Standard Snellen Static Chart	Baseline, Week 4	The common Snellen chart is printed with eleven lines of block letters. The first line consists of one very large letter, which may be one of several letters, for example E, H, or N. Subsequent rows have increasing numbers of letters that decrease in size. Participants will cover one eye from 6 metres or 20 feet away, and read aloud the letters of each row, beginning at the top. The smallest row that can be read accurately indicates the visual acuity in that specific eye. The test will be repeated covering the opposite eye.

Trial Locations

Locations (1)

Atlanta VA Medical Center; 🇺🇸 Atlanta, Georgia, United States