Carbidopa-Levodopa in Dry AMD With Geographic Atrophy

• Status: Active, not recruiting
• Trial end date: 2021-03-01
• 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 Neovascular AMD, and measure the effects on visual acuity and retinal abnormalities due to "wet" (neovascular) AMD. The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients with Dry AMD and Geographic Atrophy, and measure the effects on visual acuity, area of geographic atrophy and other retinal abnormalities due to "dry" AMD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

1. A diagnosis of dry AMD with geographic atrophy in one or both eyes. In patients with geographic atrophy in both eyes, the eye with the larger area of geographic atrophy will be designated eye A and the eye with the smaller area of geographic atrophy will be designated eye B.

2. Normal or dry AMD of any grade in the second eye;

3. Age 50-85 years;

4. Willingness to maintain AREDS vitamin supplements throughout the study, or remain off these supplements for the duration of the study, if not taking them prior to the study;

5. Signed Informed Consent.

Exclusion criteria:

1. Any previous or current use of L-DOPA containing medication or dopamine agonist medication, or any planned use of any of these agents, except for study medication, during the study;

2. Concurrent use of monoamine oxidase (MAO) inhibitors;

3. Any eye condition, disease, or history of trauma in either eye, which can impair vision, except cataract or cataract surgery;

4. BCVA worse than 20/100 in the eye with better BCVA;

5. Current, or history of, neovascular AMD in either eye;

6. Neurologic conditions which can impair vision;

7. Parkinson's Disease;

8. 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;

9. Significant ECG abnormalities, as judged by the Investigator;

10. Estimated glomerular filtration rate (eGFR) <20 ml/min;

11. Liver enzymes >3 X the upper limit of normal;

12. HbA1C >9.0;

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

14. Women of childbearing potential;

15. Known retinal hemorrhage;

16. Subjects who are not fluent in English.