Status:
TERMINATED
Carbidopa-Levodopa in Dry AMD With Geographic Atrophy
Lead Sponsor:
Snyder, Robert W., M.D., Ph.D., P.C.
Conditions:
Age Related Macular Degeneration
Eligibility:
All Genders
50-85 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Age-related macular degeneration (AMD) is the most common cause of blindness, in individuals over the age of 50, in the developed world. AMD becomes more common as people age, and is more common in li...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
- Normal or dry AMD of any grade in the second eye;
- Age 50-85 years;
- 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;
- Signed Informed Consent.
- Exclusion criteria:
- 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;
- Concurrent use of monoamine oxidase (MAO) inhibitors;
- Any eye condition, disease, or history of trauma in either eye, which can impair vision, except cataract or cataract surgery;
- BCVA worse than 20/100 in the eye with better BCVA;
- Current, or history of, neovascular AMD in either eye;
- Neurologic conditions which can impair vision;
- Parkinson's Disease;
- 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) \<20 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 of childbearing potential;
- Known retinal hemorrhage;
- Subjects who are not fluent in English.
Exclusion
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2019
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03451500
Start Date
July 1 2018
End Date
October 31 2019
Last Update
April 25 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Robert W Snyder, MD, PhD, PC
Tucson, Arizona, United States, 85712