DiabetesPhase 1Dopamine DRNCT02706977
The Effect of Dopamine on Diabetic Retinopathy
A Phase 1 study testing Low Dose Sinemet CR, High Dose Sinemet CR and RETeval Electroretinogram (ERG) Testing in people with Diabetes, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Low Dose Sinemet CR, High Dose Sinemet CR and RETeval Electroretinogram (ERG) Testing
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 15 Aug 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants with Diabetes Mellitus:
- Diagnosis of diabetes mellitus type-2
- HbA1c between 8 and 12%
- Age-Matched Controls:
- Non-diabetic
Who cannot join
- 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:
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Low Dose Sinemet CR, High Dose Sinemet CR, RETeval Electroretinogram (ERG) Testing, Contrast Sensitivity Testing, Visual Acuity Testing
- Keywords
- Ophthalmology
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose Sinemet CRDrug
Sinemet CR (25 mg carbidopa/100 mg levodopa) will be taken by mouth twice daily for two weeks.
High Dose Sinemet CRDrug
Sinemet CR (50 mg carbidopa/200 mg levodopa) will be taken by mouth twice daily for two weeks.
RETeval Electroretinogram (ERG) TestingDevice
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 TestingOther
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.
Visual Acuity TestingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Group - Low Dose Sinemet CR | Experimental | Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive low dose Sinemet CR twice daily for two weeks. Receives: Drug: Low Dose Sinemet CR; Device: RETeval Electroretinogram (ERG) Testing; Other: Contrast Sensitivity Testing; Other: Visual Acuity Testing |
| Diabetes Group - High Dose Sinemet CR | Experimental | Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive high dose Sinemet CR twice daily for two weeks. Receives: Drug: High Dose Sinemet CR; Device: RETeval Electroretinogram (ERG) Testing; Other: Contrast Sensitivity Testing; Other: Visual Acuity Testing |
| Diabetes Group - No Electroretinogram (ERG) Delays | Other | Participants with diabetes mellitus type-2 who do not have electroretinogram (ERG) delays. Participants in this group will have one baseline visit only. Receives: Device: RETeval Electroretinogram (ERG) Testing; Other: Contrast Sensitivity Testing; Other: Visual Acuity Testing |
| Age-Matched Controls | Other | 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. Receives: Device: RETeval Electroretinogram (ERG) Testing; Other: Contrast Sensitivity Testing; Other: Visual Acuity Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 4
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.
Measured: Baseline, Week 4
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.
Measured: Baseline, Week 4
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.
Measured: Baseline, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startJan 2016
- Primary completion15 Aug 2019
- Study completion15 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Machelle Pardue, Emory University
- Investigators
- Machelle Pardue, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706977
- Sponsor's protocol ID
- IRB00083672
- Acronym
- Dopamine DR
- Status last verified
- Oct 2019
- First submitted
- 4 Mar 2016
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32051147
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dopamine on Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT02706977
- Acronym / sponsor ID
- Dopamine DR / IRB00083672
- Conditions
- Diabetes
- Keywords
- Ophthalmology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 11 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diabetes Group - Low Dose Sinemet CR | Experimental | Drug: Low Dose Sinemet CR, Device: RETeval Electroretinogram (ERG) Testing, Other: Contrast Sensitivity Testing, Other: Visual Acuity TestingParticipants 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 | Experimental | Drug: High Dose Sinemet CR, Device: RETeval Electroretinogram (ERG) Testing, Other: Contrast Sensitivity Testing, Other: Visual Acuity TestingParticipants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive high dose Sinemet CR twice daily for two weeks. |
| Diabetes Group - No Electroretinogram (ERG) Delays | Other | Device: RETeval Electroretinogram (ERG) Testing, Other: Contrast Sensitivity Testing, Other: Visual Acuity TestingParticipants 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 | Other | Device: RETeval Electroretinogram (ERG) Testing, Other: Contrast Sensitivity Testing, Other: Visual Acuity TestingParticipants will serve as age-matched controls for participants with diabetes. This group will participate in the baseline, week 2, and week 4 visits only. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of diabetes mellitus type-2
- HbA1c between 8 and 12%
- Non-diabetic
Key exclusion criteria (11 listed)
- 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
- Diabetes diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Dose Sinemet CRSinemet CR (25 mg carbidopa/100 mg levodopa) will be taken by mouth twice daily for two weeks. | Drug | Diabetes Group - Low Dose Sinemet CR |
| High Dose Sinemet CRSinemet CR (50 mg carbidopa/200 mg levodopa) will be taken by mouth twice daily for two weeks. | Drug | Diabetes Group - High Dose Sinemet CR |
| RETeval Electroretinogram (ERG) TestingERG 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. | Device | Age-Matched Controls, Diabetes Group - High Dose Sinemet CR, Diabetes Group - Low Dose Sinemet CR, Diabetes Group - No Electroretinogram (ERG) Delays |
| Contrast Sensitivity TestingContrast 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 | Age-Matched Controls, Diabetes Group - High Dose Sinemet CR, Diabetes Group - Low Dose Sinemet CR, Diabetes Group - No Electroretinogram (ERG) Delays |
| Visual Acuity TestingParticipants 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, Diabetes Group - High Dose Sinemet CR, Diabetes Group - Low Dose Sinemet CR, Diabetes Group - No Electroretinogram (ERG) Delays |
Primary outcome
Change in Retinal Function assessed by Electroretinogram (ERG) Device
Time frame: 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 Contrast Sensitivity Function v1.0 (CSF v1.0) Tablet Application
Time frame: 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 Contrast Sensitivity assessed by the Sine Wave Grafting Test (CSV-1000E)
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Derived from this study: PubMed 32051147Motz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Machelle Pardue, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low Dose Sinemet CR, High Dose Sinemet CR and RETeval Electroretinogram (ERG) Testing in people with Diabetes, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Retinal Function assessed by Electroretinogram (ERG) Device (time frame: Baseline, Week 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02706977, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.