Extension, Carbidopa-levodopa in Neovascular Age-related Macular Degeneration (AMD)

NCT ID: NCT03197493

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2020-07-09

Brief 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.

Detailed 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.

Conditions

Macula; Degeneration; Retina

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Carbidopa/levodopa high dose

carbidopa-levodopa 25-100 mg 2 tablets TID

Group Type: EXPERIMENTAL

carbidopa-levodopa 25-100 mg

Intervention Type: DRUG

High Dose: daily oral administration 2 tablets TID Intermediate Dose: daily oral administration 1 tablet TID

Interventions

carbidopa-levodopa 25-100 mg

High Dose: daily oral administration 2 tablets TID Intermediate Dose: daily oral administration 1 tablet TID

Intervention Type: DRUG

Other Intervention Names

Sinemet

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Snyder Biomedical Corporation

OTHER

Sponsor Role: collaborator

Snyder, Robert W., M.D., Ph.D., P.C.

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert W Snyder, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Robert W Snyder

Locations

Robert W Snyder, MD, PhD, PC

Tucson, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

0003

Identifier Type: -

Identifier Source: org_study_id