Clinical trial NCT02706977: The Effect of Dopamine on Diabetic Retinopathy
Official title: The Effect of Dopamine on Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Keywords: Ophthalmology
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-03-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Retinal Function assessed by Electroretinogram (ERG) Device
timeFrame: Baseline, Week 4
measure: Change in Contrast Sensitivity assessed by the Contrast Sensitivity Function v1.0 (CSF v1.0) Tablet Application
timeFrame: Baseline, Week 4
measure: Change in Contrast Sensitivity assessed by the Sine Wave Grafting Test (CSV-1000E)
timeFrame: Baseline, Week 4
measure: Change in Visual Acuity assessed by the Standard Snellen Static Chart
timeFrame: Baseline, Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta VA Medical Center
state: Georgia
Study officials:
affiliation: Emory University
name: Machelle Pardue, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.