Extension, Carbidopa-levodopa in Neovascular AMD
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 50 - 85 |
Updated: | 4/6/2019 |
Start Date: | August 1, 2017 |
End Date: | March 2021 |
Contact: | Timothy C Fagan, MD |
Email: | tcfaganmd@gmail.com |
Phone: | 5204045801 |
Extension of Protocol 002, Carbidopa-levodopa in Neovascular Extension of Protocol 002, Carbidopa-levodopa in Neovascular AMD
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.
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.
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.
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.
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.
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