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 — DRUG25 mg carbidopa/100 mg levodopa
- placebo — DRUGPlacebo 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: Sinemet25 mg carbidopa/100 mg levodopa
- Placebo Comparator: PlaceboPlacebo pill of similar size/shape
- No Intervention: follow-upFollow-up testing on participants previously prescribed levodopa
Primary Outcome Measure
Electroretinogram [ Time Frame: 24 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia | 30033-4004 | - |
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