Levodopa for Diabetic Retinopathy

Part of paid clinical trials in Decatur, Georgia.

Sponsor
Emory University
Study ID
NCT07444892
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Levodopa — DRUG
    Patients will receive tablets of generic 25 mg carbidopa/100 mg levodopa as the drug treatment.
  • Placebo — DRUG
    Patients will receive matching placebo tablets as the drug treatment.

Study Details

The purpose of this study is to determine optimum dosing strategies of levodopa and determine the physiologic mechanisms that provide the therapeutic response to restore abnormalities in the electrical conductivity of the retina in people with diabetes and no clinically visible retinopathy.

Key Dates

Start date
Apr 18, 2022
Status verified
Feb 2026
Primary completion
Nov 17, 2025
Completion
Nov 17, 2025

Study Design

Enrollment
230 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Placebo
    Diabetic participants will be instructed to take the oral placebo daily with a meal for 6 months.
  • Experimental: Levodopa every other day
    Diabetic participants will be instructed to take the levodopa every other day with a meal for 6 months.
  • Experimental: Levodopa once per day
    Diabetic participants will be instructed to take the oral levodopa daily with a meal for 6 months..
  • Experimental: Levodopa twice per day
    Diabetic participants in the twice per day group will be instructed to take the drug 12 hours apart every day for 6 months.

Primary Outcome Measure

ERG with dim flash stimuli [ Time Frame: Baseline, 3 and 6 months post-intervention ]

Locations (1)

FacilityCityStateZIPSite coordinators
Atlanta VA Medical CenterDecaturGeorgia30033-

Find similar trials in Decatur, GA

Related Studies