NCT05132660

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for early_phase_1

Timeline
32mo left

Started Jul 2022

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Jul 2022Dec 2028

First Submitted

Initial submission to the registry

November 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 4, 2025

Status Verified

May 1, 2025

Enrollment Period

5.5 years

First QC Date

November 22, 2021

Last Update Submit

May 1, 2025

Conditions

Diabetic Retinopathy

Keywords

diabetes

Outcome Measures

Primary Outcomes (1)

  • Electroretinogram

    Electrical activity of the retina measured by non-invasive electrodes on the face to a flash to light. A waveform will be recorded and timing of the waves measured in milliseconds

    24 months

Secondary Outcomes (3)

  • Optical coherence tomography angiography

    24 months

  • Fundus photographs

    24 months

  • HbA1c

    24 months

Study Arms (3)

Sinemet

EXPERIMENTAL

25 mg carbidopa/100 mg levodopa

Drug: Sinemet CR

Placebo

PLACEBO COMPARATOR

Placebo pill of similar size/shape

Drug: placebo

follow-up

NO INTERVENTION

Follow-up testing on participants previously prescribed levodopa

Interventions

Sinemet CRDRUG

25 mg carbidopa/100 mg levodopa

Also known as: Levodopa
Sinemet
placeboDRUG

Placebo pill of similar size/shape

Placebo

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

Location

MeSH Terms

Conditions

Diabetic RetinopathyDiabetes Mellitus

Interventions

carbidopa, levodopa drug combinationLevodopa

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosine

Study Officials

  • Machelle T. Pardue, PhD

    Atlanta VA Medical and Rehab Center, Decatur, GA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants will be assigned a number and treatment group will be assigned according to randomization strategy by pharmacy personnel
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Sinemet CR 25 mg carbidopa/100 mg levodopa or placebo will be given twice daily for 6 months or 24 months.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2021

First Posted

November 24, 2021

Study Start

July 1, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

May 4, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)