By InvitationEarly Phase 1

Treating Early Stage Diabetic Retinopathy

United States244 participantsStarted 2022-07-01

Plain-language 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.

Who can participate

Age range30 Years – 80 Years

SexALL

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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

What they're measuring

Electroretinogram

Timeframe: 24 months

Trial details

NCT IDNCT05132660

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Diabetic Retinopathy trials