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A Safety and Efficacy Study of Carbidopa-levodopa in Patients With Macular Degeneration

NCT02873351 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-04-05

No results posted yet for this study

Summary

From 3 large patient databases, patients diagnosed with AMD who have never taken levodopa(L-DOPA) containing medications have a mean age of diagnosis at 71 years. Patients who have been treated with L-DOPA containing medications have a mean age of diagnosis of AMD at 79 years.

L-DOPA binds to GPR143 in the retinal pigment epithelium, and releases PEDF, which protects the retina and downregulates VEGF, which is the cause of neovascularization.

The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients with AMD, and measure the effects on surrogate functional biomarkers of AMD.

Conditions

  • Age-related Macular Degeneration

Interventions

DRUG

carbidopa-levodopa 25-100 mg

included in arm description

DRUG

placebo for carbidopa-levodopa 25-100 mg

included in arm description

Sponsors & Collaborators

  • Snyder, Robert W., M.D., Ph.D., P.C.

    lead INDIV

Principal Investigators

  • Robert W Snyder, MD, PhD · Robert W Snyder, MD, PhD, PC

  • Timothy C Fagan, MD · Robert W Snyder, MD, PhD, PC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02873351 on ClinicalTrials.gov