Overview

Treating Early Stage Diabetic Retinopathy

Status:
Not yet recruiting
Trial end date:
2028-12-31
Target enrollment:
0
Participant gender:
All
Summary
To determine if levodopa will slow the appearance of blood vessel changes in the eyes of patients with diabetes. Treatment will be started in patients with diabetes show delays in the electrical activity of the retina when measured non-invasively with a electroretinogram.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
VA Office of Research and Development
Collaborator:
Emory University
Treatments:
Carbidopa, levodopa drug combination
Levodopa
Criteria
Inclusion Criteria:

- HbA1c 8-12%

- Diabetic patients with no retinopathy as screened with teleretinal imaging

- Diabetic patients with microaneurysms as detected with fundus teleretinal screening

- ERG oscillatory potential delays in response to dim flash stimuli

Exclusion Criteria:

- Patients with pituitary tumor, psychosis, Parkinson's disease

- Patients with confounding ocular disease (visually significant cataract, glaucoma,
macular degeneration, retinitis pigmentosa)

- Patients with cognitive deficits (score of 24 or less on the Montreal Cognitive

- Assessment-MOCA

- No anti-VEGF or steroid treatments within the last 12 months

- Pregnancy