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

NCT03197493 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 0003
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Macula; Degeneration; Retina

Outcome Measures

Primary Outcomes (1)

• Change in Best Corrected Visual Acuity by ETDRS Visual Scale Testing

  This outcome is a measure of letters correctly identified using an Early Treatment Diabetic Retinopathy Study chart. The higher the number of letters identified, the better the participant's visual acuity.

  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 12), a maximum of 9 months following a 3 month enrollment in NCT03023059.

Secondary Outcomes (3)

• Number of Adverse Events Experienced

  Monthly for 9 months

• Change in Central Retinal (Macular) Thickness

  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, a maximum of 9 months.

• Percent Change in Retinal Fluid From Baseline

  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.

Study Arms (1)

Carbidopa/levodopa high dose

EXPERIMENTAL

carbidopa-levodopa 25-100 mg 2 tablets TID

Drug: carbidopa-levodopa 25-100 mg

Interventions

carbidopa-levodopa 25-100 mg DRUG

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

Also known as: Sinemet

Carbidopa/levodopa high dose

Eligibility Criteria

• Age: 50 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completion of Protocol 002.
• A diagnosis of AMd with choroidal neovascularization (CNV) in 1 eye.
• 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 of these supplements for the duration of the study, if not taking them prior to the study.
• Informed consent at visit 1, which is also Visit 5 of study 002.

You may not qualify if:

• 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;
• 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 20/60 in the better eye;
• Wet AMD in the second 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;

Sponsors & Collaborators

• Snyder, Robert W., M.D., Ph.D., P.C.: lead
• Snyder Biomedical Corporation: collaborator

Study Sites (1)

Robert W Snyder, MD, PhD, PC

Tucson, Arizona, 85712, United States

Location

MeSH Terms

Interventions

carbidopa, levodopa drug combination

Limitations and Caveats

The major limitations of our study include the small sample size and limited patient racial diversity.

Results Point of Contact

• Title: Dr. Robert W. Snyder
• Organization: Robert W Snyder, MD, PhD, PC

rsnyder781@gmail.com

5206616516

Study Officials

• Robert W Snyder, MD, PhD

  Robert W Snyder

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Model Details: Patients who complete 3 months of escalation dose carbidopa-levodopa, will receive 9 additional months of therapy with the highest dose used in protocol 0002, carbidopa-levodopa 25-100 mg 2 tablets TID.

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 23, 2017
• Study Start: August 1, 2017
• Primary Completion: July 9, 2020
• Study Completion: July 9, 2020
• Last Updated: September 12, 2025
• Results First Posted: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)