Extension, Carbidopa-levodopa in Neovascular AMD

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

Status and phase: Completed; Phase 2

Conditions: Retina; Macula; Degeneration

Treatments: Drug: carbidopa-levodopa 25-100 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03197493

0003

Details and patient eligibility

About

This protocol is an extension of protocol 0002, Proof of Concept and Dose Ranging Study of carbidopa-levodopa in Neovascular AMD. that is a 3 month study of escalating doses of carbidopa-levodopa in neovascular AMD. This trial is a 9 month extension for patients who successfully complete protocol 0002 and wish to continue carbidopa-levodopa therapy. It will use the two higher dose regimens of protocol 0002. these will be assigned according to how well the higher dose was tolerated in protocol 0002.

Full description

This extension will employ the same medications, measurements, guidelines for anti-VEGF injections and safeguards as in protocol 0002. In combination with protocol 0002, it will provide a total of 12 months of therapy with carbidopa-levodopa.

Enrollment: 32 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Completion of Protocol 002.
2. A diagnosis of AMd with choroidal neovascularization (CNV) in 1 eye.
3. Normal or Dry AMD of any grade in the second eye.
4. Age 50-85 years.
5. Willingness to maintain AREDS vitamin Supplements throughout the study, or remain off of these supplements for the duration of the study, if not taking them prior to the study.
6. Informed consent at visit 1, which is also Visit 5 of study 002.

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

High Dose

Experimental group

Description:

carbidopa-levodopa 25-100 mg 2 tablets TID

Treatment:

Drug: carbidopa-levodopa 25-100 mg

Intermediate Dose

Experimental group

Description:

carbidopa-levodopa 25-100 mg 1 tablet TID

Treatment:

Drug: carbidopa-levodopa 25-100 mg