- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02706977
The Effect of Dopamine on Diabetic Retinopathy (Dopamine DR)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30033
- Atlanta VA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Diabetes Group - 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.
|
Sinemet CR (25 mg carbidopa/100 mg levodopa) will be taken by mouth twice daily for two weeks.
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.
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.
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.
|
EXPERIMENTAL: Diabetes Group - 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.
|
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.
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.
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.
Sinemet CR (50 mg carbidopa/200 mg levodopa) will be taken by mouth twice daily for two weeks.
|
OTHER: Diabetes Group - No Electroretinogram (ERG) Delays
Participants with diabetes mellitus type-2 who do not have electroretinogram (ERG) delays.
Participants in this group will have one baseline visit only.
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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.
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.
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.
|
OTHER: Age-Matched Controls
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.
|
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Retinal Function assessed by Electroretinogram (ERG) Device
Time Frame: Baseline, Week 4
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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.
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Baseline, Week 4
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Change in Contrast Sensitivity assessed by the Contrast Sensitivity Function v1.0 (CSF v1.0) Tablet Application
Time Frame: Baseline, Week 4
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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.
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Baseline, Week 4
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Change in Contrast Sensitivity assessed by the Sine Wave Grafting Test (CSV-1000E)
Time Frame: Baseline, Week 4
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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.
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Baseline, Week 4
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Change in Visual Acuity assessed by the Standard Snellen Static Chart
Time Frame: Baseline, Week 4
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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.
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Baseline, Week 4
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Machelle Pardue, PhD, Emory University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Diseases
- Diabetic Retinopathy
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Immunologic Factors
- Dopamine Agonists
- Dopamine Agents
- Adjuvants, Immunologic
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Aromatic Amino Acid Decarboxylase Inhibitors
- Levodopa
- Carbidopa
- Carbidopa, levodopa drug combination
Other Study ID Numbers
- IRB00083672
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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