Back to resultsThe Effect of Dopamine on Diabetic Retinopathy (Dopamine DR)
Primary Purpose
Diabetes
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Low Dose Sinemet CR
High Dose Sinemet CR
RETeval Electroretinogram (ERG) Testing
Contrast Sensitivity Testing
Visual Acuity Testing
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes focused on measuring Ophthalmology
Eligibility 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
Sites / Locations
- Atlanta VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Other
Other
Arm Label
Diabetes Group - Low Dose Sinemet CR
Diabetes Group - High Dose Sinemet CR
Diabetes Group - No Electroretinogram (ERG) Delays
Age-Matched Controls
Arm Description
Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive low dose Sinemet CR twice daily for two weeks.
Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive high dose Sinemet CR twice daily for two weeks.
Participants with diabetes mellitus type-2 who do not have electroretinogram (ERG) delays. Participants in this group will have one baseline visit only.
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.
Outcomes
Primary Outcome Measures
Change in Retinal Function assessed by Electroretinogram (ERG) Device
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 Contrast Sensitivity Function v1.0 (CSF v1.0) Tablet Application
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 Contrast Sensitivity assessed by the Sine Wave Grafting Test (CSV-1000E)
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02706977
Brief Title
The Effect of Dopamine on Diabetic Retinopathy
Acronym
Dopamine DR
Official Title
The Effect of Dopamine on Diabetic Retinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
August 15, 2019 (Actual)
Study Completion Date
August 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
Keywords
Ophthalmology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diabetes Group - Low Dose Sinemet CR
Arm Type
Experimental
Arm Description
Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive low dose Sinemet CR twice daily for two weeks.
Arm Title
Diabetes Group - High Dose Sinemet CR
Arm Type
Experimental
Arm Description
Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive high dose Sinemet CR twice daily for two weeks.
Arm Title
Diabetes Group - No Electroretinogram (ERG) Delays
Arm Type
Other
Arm Description
Participants with diabetes mellitus type-2 who do not have electroretinogram (ERG) delays. Participants in this group will have one baseline visit only.
Arm Title
Age-Matched Controls
Arm Type
Other
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Low Dose Sinemet CR
Intervention Description
Sinemet CR (25 mg carbidopa/100 mg levodopa) will be taken by mouth twice daily for two weeks.
Intervention Type
Drug
Intervention Name(s)
High Dose Sinemet CR
Intervention Description
Sinemet CR (50 mg carbidopa/200 mg levodopa) will be taken by mouth twice daily for two weeks.
Intervention Type
Device
Intervention Name(s)
RETeval Electroretinogram (ERG) Testing
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Contrast Sensitivity Testing
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Visual Acuity Testing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Retinal Function assessed by Electroretinogram (ERG) Device
Description
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.
Time Frame
Baseline, Week 4
Title
Change in Contrast Sensitivity assessed by the Contrast Sensitivity Function v1.0 (CSF v1.0) Tablet Application
Description
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.
Time Frame
Baseline, Week 4
Title
Change in Contrast Sensitivity assessed by the Sine Wave Grafting Test (CSV-1000E)
Description
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.
Time Frame
Baseline, Week 4
Title
Change in Visual Acuity assessed by the Standard Snellen Static Chart
Description
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.
Time Frame
Baseline, Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Machelle Pardue, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta VA Medical Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32051147
Citation
Motz CT, Chesler KC, Allen RS, Bales KL, Mees LM, Feola AJ, Maa AY, Olson DE, Thule PM, Iuvone PM, Hendrick AM, Pardue MT. Novel Detection and Restorative Levodopa Treatment for Preclinical Diabetic Retinopathy. Diabetes. 2020 Jul;69(7):1518-1527. doi: 10.2337/db19-0869. Epub 2020 Feb 12.
Results Reference
derived
Learn more about this trial
The Effect of Dopamine on Diabetic Retinopathy
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