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

• Status: Withdrawn
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Snyder, Robert W., M.D., Ph.D., P.C.
• Treatments: Carbidopa; Carbidopa, levodopa drug combination; Levodopa

Criteria

1. Inclusion Criteria:

• - A diagnosis of intermediate or advanced dry AMD in at least one eye. The other eye may be normal or have any stage of AMD.

• - If the participant is taking AREDS vitamin supplements, these supplements must be continued for the duration of the study. If the participant is not taking AREDS vitamin supplements, these supplements must not be started during the study.

2. Exclusion Criteria:

• - Any previous prescription for L-DOPA or dopamine agonist medications, or any planned use of any of these agents, except for study medication, during the study;

• - Concurrent use of monoamine oxidase (MAO) inhibitors;

• - With the exception of AMD or cataract or previous cataract operation; any eye condition, disease, history of surgery, or trauma in either eye, which can impair vision;

• - Neurologic conditions which can impair vision;

• - Parkinson's Disease;

• - Dark adaptation rod intercept < 6.5 minutes;

• - Significant orthostatic hypotension, defined as a drop in systolic blood pressure, immediately upon changing from the supine to standing position, of >19 mmHg, or a symptomatic drop in systolic blood pressure, immediately upon changing from the supine to standing position;

• - Significant ECG abnormalities, as judged by the Investigator;

• - Estimated glomerular filtration rate (eGFR) <30 ml/min;

• - Liver enzymes >3 X the upper limit of normal;

• - HbA1C >9.0;

• - Any other significant lab abnormalities, as judged by the Investigator.

• - Women with childbearing potential;

• -Subjects who are not fluent in English.