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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT02873351
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT02873351
Study Brief:
Protocol Section:
NCT02873351