Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT03023059
Eligibility 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. Best Corrected Visual Acuity (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. -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT03023059
Study Brief:
Protocol Section:
NCT03023059