Extension, Carbidopa-levodopa in Neovascular AMD

Retina Clinical Trial

Official title:

Extension of Protocol 002, Carbidopa-levodopa in Neovascular Extension of Protocol 002, Carbidopa-levodopa in Neovascular AMD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03197493
• Other study ID #: 0003
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2017
• Est. completion date: July 9, 2020

Study information

• Verified date: December 2020
• Source: Snyder, Robert W., M.D., Ph.D., P.C.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 9, 2020
• Est. primary completion date: July 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Macula; Degeneration
• Retina

Intervention

Drug:
• carbidopa-levodopa 25-100 mg
High Dose: daily oral administration 2 tablets TID Intermediate Dose: daily oral administration 1 tablet TID

Locations

Country	Name	City	State
United States	Robert W Snyder, MD, PhD, PC	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Snyder, Robert W., M.D., Ph.D., P.C.	Snyder Biomedical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Visual Acuity by ETDRS visual scale testing	Currently refracted, normal light, lines and letters read on the ETDRS chart	From the start of the study (Visit 1) to the last completed visit, whether due to patient withdrawal, patient death or the completion of the last visit of the study (visit 10), a maximum of 9 months.
Secondary	Number of adverse events experienced by participants during the study	Adverse events elicited by nonspecific questioning	Monthly for 9 months
Secondary	By OCT, central retinal thickness, in the eye with neovascular AMD	Central retinal thickness by OCT	From the start of the study (Visit 1) to the last completed visit, whether due to patient withdrawal, patient death or the completion of the last visit of the study (visit 10), a maximum of 9 months.
Secondary	By OCT, drusen volume in the eye without neovascular AMD	drusen volume	From the start of the study (Visit 1) to the last completed visit, whether due to patient withdrawal, patient death or the completion of the last visit of the study, (visit 10), a maximum of 9 months.