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Trial record 1 of 18 for:    Sinemet® | Recruiting, Not yet recruiting, Available Studies
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Dose Ranging Study of Carbidopa-levodopa

This study is currently recruiting participants.
Verified October 2017 by Snyder, Robert W., M.D., Ph.D., P.C.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03023059
First Posted: January 18, 2017
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Snyder, Robert W., M.D., Ph.D., P.C.
  Purpose

From 3 large patient databases, patients diagnosed with AMD who have never taken levodopa(L-DOPA) containing medications have a mean age of diagnosis at 71 years. Patients who have been treated with L-DOPA containing medications have a mean age of diagnosis of AMD at 79 years.

L-DOPA binds to GPR143 in the retinal pigment epithelium, and releases PEDF, which protects the retina and downregulates VEGF, which is the cause of neovascularization.

The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients with Neovascular AMD, and measure the effects on visual acuity and retinal abnormalities due to "wet" (neovascular) AMD.

The Investigators will evaluate the safety and tolerability of carbidopa-levodopa in patients with Neovascular AMD who are already on treatment with anti-VEGF intraocular injections, and measure the effects on visual acuity, retinal abnormalities due to "wet" AMD, and document the number of anti-VEGF injections required during the study.


Condition Intervention Phase
Age-related Macular Degeneration Drug: Carbidopa-Levodopa, 25 Mg-100 Mg Oral Tablet Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proof of Concept and Dose Ranging Study of Carbidopa-levodopa in Neovascular AMD

Resource links provided by NLM:


Further study details as provided by Snyder, Robert W., M.D., Ph.D., P.C.:

Primary Outcome Measures:
  • Change in ETDRS visual acuity [ Time Frame: From start of study to end (78-112 days) ]
    Visual acuity measured with optimum optical correction, using a standard ETDRS chart


Secondary Outcome Measures:
  • Change in central retinal (macular) thickness [ Time Frame: From start of study to end (78-112 days) ]
    Central retinal thickness measured by SD OCT

  • New retinal blood (hemorrhage) [ Time Frame: From start of study to end (78-112 days) ]
    Visible blood on direct retinal examination

  • Treatment Emergent Adverse Events [ Time Frame: From start of study to end (78-112 days) ]
    Vital signs, eye examinations and nondirected subjective adverse events


Estimated Enrollment: 52
Actual Study Start Date: May 2, 2017
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Escalating dose of carbidopa-levodopa
The intervention is that patients will receive open label, commercially available Carbidopa-Levodopa 25 Mg-100 Mg oral tablet, once daily hs for one month, followed by one tablet dosed three times daily, in the morning, with supper and hs for one month, followed by two tablets dosed three times daily, in the morning, with supper and hs for one month (100-600 mg of levodopa daily). This is the equivalent of very low to moderate doses of carbidopa-levodopa in patients with Parkinson's disease (daily dose of levodopa 200-800 mg).
Drug: Carbidopa-Levodopa, 25 Mg-100 Mg Oral Tablet
See Arm description
Other Name: Sinemet

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A diagnosis of AMD with choroidal neovascularization (CNV) in one eye;
  2. a. Not previously treated with anti-VEGF injections; or

    b. On anti-VEGF injections for at least 3 months, and meets criteria for a repeat injection; or

    c. Patients, who have completed Study 001, may enter this trial at the point of initiation of the month of treatment with the dose of carbidopa-levodopa, that they received in Study 001;

  3. Normal or dry AMD of any grade in the second eye;
  4. Willingness to maintain AREDS vitamin supplements throughout the study, or remain off these supplements for the duration of the study, if not taking them prior to the study;
  5. Informed Consent at Baseline.

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. -
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023059


Contacts
Contact: Timothy C Fagan, MD (520) 404-5801 tcfaganmd@gmail.com
Contact: Robert W Snyder, MD,PhD (520) 661-6516 rsnyder781@gmail.com

Locations
United States, Arizona
Robert W Snyder, MD, PhD, PC Recruiting
Tucson, Arizona, United States, 85712
Contact: Timothy C Fagan, MD    520-404-5801    tcfaganmd@gmail.com   
Contact: Robert W Snyder, MD    (520) 661-6516    rsnyder781@gmail.com   
Sponsors and Collaborators
Snyder, Robert W., M.D., Ph.D., P.C.
Investigators
Principal Investigator: Robert W Snyder, MD, PhD Robert W Snyder, MD, PhD, PC
Study Director: Timothy C Fagan, MD Robert W Snyder, MD, PhD, PC
  More Information

Publications:
Westfall TC, Westfall DP. Neurotransmission: The Autonomic and Somatic Nervous Systems. Pharmacological Basis of Therapeutics, 12th Edition, 171-218, McGraw-Hill, 2011.
Standaert DG, Roberson ED. Treatment of Central Nervous System Degenerative Disorders. Pharmacological Basis of Therapeutics, 12th Edition, 609-628, McGraw-Hill, 2011

Responsible Party: Snyder, Robert W., M.D., Ph.D., P.C.
ClinicalTrials.gov Identifier: NCT03023059     History of Changes
Other Study ID Numbers: 0002
First Submitted: January 13, 2017
First Posted: January 18, 2017
Last Update Posted: October 23, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Snyder, Robert W., M.D., Ph.D., P.C.:
L-DOPA
GPR143
PEDF
VEGF

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Levodopa
Carbidopa
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists