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Carbidopa-Levodopa in Dry AMD With Geographic Atrophy

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ClinicalTrials.gov Identifier: NCT03451500
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Snyder, Robert W., M.D., Ph.D., P.C.

Brief Summary:

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 Dry AMD and Geographic Atrophy, and measure the effects on visual acuity, area of geographic atrophy and other retinal abnormalities due to "dry" AMD.


Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration Drug: carbidopa-levodopa Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, prospective, placebo controlled
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: All tablets will be identical in appearance. The Director of Research will be aware of treatment assignment. Patients, their Care Providers and all other study staff will be blinded to treatment.
Primary Purpose: Treatment
Official Title: Carbidopa-Levodopa in Dry Age Related Macular Degeneration With Geographic Atrophy
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Carbidopa-levodopa 2 tablets daily
carbidopa-levodopa 25-100 mg 2 tablets daily hs
Drug: carbidopa-levodopa
See previous

Experimental: carbidopa-levodopa 6 tablets daily
carbidopa-levodopa 25-100 mg, 2 tablets, 3 times daily, with breakfast, with supper and hs
Drug: carbidopa-levodopa
See previous

Placebo Comparator: Placebo
Placebo, 2 tablets, 3 times daily, with breakfast, with supper and hs
Drug: carbidopa-levodopa
See previous




Primary Outcome Measures :
  1. Area of Geographic Atrophy [ Time Frame: Change over 12 months ]
    area of retinal geographic atrophy measured by fundus autofluorescence


Secondary Outcome Measures :
  1. Best Corrected Visual Acuity by ETDRS [ Time Frame: Change over 12 months ]
    Best Corrected Visual Acuity by ETDRS

  2. Central retinal thickness [ Time Frame: Change over 12 months ]
    Central Retinal Thickness, measured by SD-OCT

  3. Development of neovascular macular degeneration [ Time Frame: New diagnosis during 12 months of treatment ]
    New diagnosis of neovascular macular degeneration



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. A diagnosis of dry AMD with geographic atrophy in one or both eyes. In patients with geographic atrophy in both eyes, the eye with the larger area of geographic atrophy will be designated eye A and the eye with the smaller area of geographic atrophy will be designated eye B.
  2. Normal or dry AMD of any grade in the second eye;
  3. Age 50-85 years;
  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. Signed Informed Consent.

Exclusion criteria:

  1. Any previous or 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 20/100 in the eye with better BCVA;
  5. Current, or history of, neovascular AMD in either 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.

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): NCT03451500


Contacts
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Contact: Timothy C Fagan, MD 5204045801 tcfaganmd@gmail.com
Contact: Robert W Snyder, MD, PhD 5206616516 rsnyder781@gmail.com

Locations
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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    5206616516    rsnyder781@gmail.com   
Sponsors and Collaborators
Snyder, Robert W., M.D., Ph.D., P.C.
Investigators
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Study Director: Timothy C Fagan, MD Robert Snyder, MD, PhD, PC
Principal Investigator: Robert W Snyder, MD, PhD Robert Snyder, MD, PhD, PC

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Responsible Party: Snyder, Robert W., M.D., Ph.D., P.C.
ClinicalTrials.gov Identifier: NCT03451500     History of Changes
Other Study ID Numbers: 0004
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.:
GPR 143
PEDF
VEGF
LDOPA

Additional relevant MeSH terms:
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Carbidopa
Carbidopa, levodopa drug combination
Macular Degeneration
Geographic Atrophy
Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Levodopa
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