Treating Early Stage Diabetic Retinopathy

Part of paid clinical trials in Decatur, Georgia.

Sponsor
VA Office of Research and Development
Study ID
NCT05132660
Phase
EARLY_PHASE1
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Sinemet CR — DRUG
    25 mg carbidopa/100 mg levodopa
  • placebo — DRUG
    Placebo pill of similar size/shape

Study Details

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.

Key Dates

Start date
Jul 1, 2022
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
244 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sinemet
    25 mg carbidopa/100 mg levodopa
  • Placebo Comparator: Placebo
    Placebo pill of similar size/shape
  • No Intervention: follow-up
    Follow-up testing on participants previously prescribed levodopa

Primary Outcome Measure

Electroretinogram [ Time Frame: 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Atlanta VA Medical and Rehab Center, Decatur, GADecaturGeorgia30033-4004-

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