Dose Ranging Study of Carbidopa-levodopa

• Status: Completed
• Trial end date: 2020-05-04
• 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 Neovascular AMD who are already on treatment with anti-VEGF intraocular injections, and measure the effects on visual acuity, retinal abnormalities due to "wet" AMD, and document the number of anti-VEGF injections required during the study.

• 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

Inclusion Criteria:

1. A diagnosis of AMD with choroidal neovascularization (CNV) in one eye;

2. a. Not previously treated with anti-VEGF injections; or

b. On anti-VEGF injections for at least 3 months, and meets criteria for a repeat injection; or

c. Patients, who have completed Study 001, may enter this trial at the point of initiation of the month of treatment with the dose of carbidopa-levodopa, that they received in Study 001;

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

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. Informed Consent at Baseline.

Exclusion Criteria:

1. Any 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 20/60 in the better eye;

5. Wet AMD in the second 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. -