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Completed

NCT Number: NCT03197493

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

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Robert W Snyder, MD, PhD, PC

Tucson, Arizona, 85712, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Subjects who are not fluent in English.

Treatment and study plan

carbidopa-levodopa 25-100 mg

Drug

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

Other names: Sinemet

Primary outcomes

  1. Change in Best Corrected Visual Acuity by ETDRS Visual Scale Testing

    Time frame: 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.

    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.

Secondary outcomes

  1. Number of Adverse Events Experienced

    Time frame: Monthly for 9 months

    Adverse events elicited by nonspecific questioning

  2. Change in Central Retinal (Macular) Thickness

    Time frame: 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.

    Central retinal thickness (in microns) is measured by spectral domain-optical coherence tomography. An increase in retinal thickness is associated with disease progression. A negative value represents a decrease in retinal thickness and therefore a positive clinical outcome measure.

  3. Percent Change in Retinal Fluid From Baseline

    Time frame: 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.

    Retinal fluid changes on direct retinal examination on spectral domain - optical coherence tomography. Changes in retinal fluid were compared to baseline values. A negative percentage point represents a decrease in retinal fluid and therefore a positive clinical outcome.

Sponsors and collaborators

Lead sponsor

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

Indiv

Collaborators

  • Snyder Biomedical Corporation

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 23, 2017
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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