The Effect of Dopamine on Diabetic Retinopathy
Completed · Phase 1
Conditions studied: Diabetes
In brief
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.
Key facts
- Study ID
- NCT02706977
- Run by
- Emory University
- People needed
- 60
- Starts
- 2016-01-01
- Expected to finish
- 2019-08-15
- Last updated by the study team
- 2019-10-09
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Participants with Diabetes Mellitus:
- Diagnosis of diabetes mellitus type-2
- HbA1c between 8 and 12%
- Age-Matched Controls:
- Non-diabetic
You may not qualify if…
- 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
Where it is running
- Atlanta VA Medical Center — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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