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A Safety and Efficacy Study of Carbidopa-levodopa in Patients With Macular Degeneration

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ClinicalTrials.gov Identifier: NCT02873351
Recruitment Status : Withdrawn (Decided to do studies in patients with AMD)
First Posted : August 19, 2016
Last Update Posted : April 5, 2019
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 AMD, and measure the effects on surrogate functional biomarkers of AMD.


Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Drug: carbidopa-levodopa 25-100 mg Drug: placebo for carbidopa-levodopa 25-100 mg Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of L-DOPA Safety and Tolerability in Patients With AMD, and Proof of Concept That L-DOPA Improves Surrogate Biomarkers in Patients With Moderate to Advanced AMD
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: carbidopa-levodopa 25-100 mg
Treatment with carbidopa-levodopa 25-100 mg tablets dosed once daily at bedtime for 45 +/- 5 days followed by carbidopa-levodopa 25-100 mg tablets dosed 3 times daily for 45 +/- 5 days.
Drug: carbidopa-levodopa 25-100 mg
included in arm description

Placebo Comparator: Placebo for carbidopa-levodopa 25-100 mg
Treatment with placebo for carbidopa-levodopa 25-100 mg in identical tablets dosed once daily at bedtime for 45 +/- 5 days followed by placebo for carbidopa-levodopa 25-100 mg tablets dosed 3 times daily for 45 +/- 5 days.
Drug: placebo for carbidopa-levodopa 25-100 mg
included in arm description




Primary Outcome Measures :
  1. Treatment Emergent Adverse Events [ Time Frame: 90 +- 10 days ]
    Treatment Emergent Adverse Events (AEs) will be assessed at each visit. These will be classified as mild, moderate or severe and by body organ system. All AEs will be specifically reassessed at each subsequent visit. Serious AEs will be reported to the institutional Review Board(IRB). All AEs will be aggregated by treatment arm.


Secondary Outcome Measures :
  1. Change from Baseline in Best Corrected Visual Acuity [ Time Frame: 45 +/- 5 days and 90 +/- 10 days ]
    After refraction to ascertain that the participant has the optimum correction for refractive error, standard visual acuity testing will be performed with an ETDRS chart. Results will be ascertained at 45 +/-5 and 90 +/- 10 days, due to different dosing during the first and second 45 day periods. Results will be aggregated by treatment arm and treatment period.

  2. Change from Baseline in Low Light Visual Acuity [ Time Frame: 45 +/- 5 days and 90 +/- 10 days ]
    Using lenses for optimum correction for refractive error, Standard visual acuity testing will be performed using an ETDRS chart under standardized low light conditions. Results will be ascertained at 45 +/- 5 and 90 +/- 10 days, due to different dosing during the first and second 45 day periods. Results will be aggregated by treatment arm and treatment period.

  3. Change from Baseline in Dark Adaptation [ Time Frame: 45 +/- 5 days and 90 +/- 10 days ]
    Using an AdaptDX machine, using standardized intensity and duration of bright light, measurement of the time after bright light exposure required to adapt to dim light will be measured using rod intercept as the measurement. Results will be ascertained at 45 +/- 5 and 90 +/- 10 days, due to different dosing during the first and second 45 day periods. Results will be aggregated by treatment arm and treatment period.

  4. Change from Baseline in Low Luminance Questionnaire Scores [ Time Frame: 45 +/- 5 days and 90 +/- 10 days ]
    This will be measured using a standard questionaire evaluating ability to function in low light conditions. Results will be tabulated by all correct answers and by number of correct answers on each subscale. Results will be ascertained at 45 +/- 5 and 90 +/- 10 days, due to different dosing during the first and second 45 day periods. Results will be aggregated by treatment arm and treatment period.

  5. Change from Baseline in Optical Coherence Tomography [ Time Frame: 45 +/- 5 days and 90 +/- 10 days ]
    Evaluating retinal structure, including drusen and reticular pseudodrusen using a standard scanning laser device. Results will be ascertained at 45 +/- 5 and 90 +/- 10 days, due to different dosing during the first and second 45 day periods. Results will be aggregated by treatment arm and treatment period.



Information from the National Library of Medicine

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

    • - A diagnosis of intermediate or advanced dry AMD in at least one eye. The other eye may be normal or have any stage of AMD.
    • - If the participant is taking AREDS vitamin supplements, these supplements must be continued for the duration of the study. If the participant is not taking AREDS vitamin supplements, these supplements must not be started during the study.
  2. Exclusion Criteria:

    • - Any previous prescription for L-DOPA or dopamine agonist medications, or any planned use of any of these agents, except for study medication, during the study;
    • - Concurrent use of monoamine oxidase (MAO) inhibitors;
    • - With the exception of AMD or cataract or previous cataract operation; any eye condition, disease, history of surgery, or trauma in either eye, which can impair vision;
    • - Neurologic conditions which can impair vision;
    • - Parkinson's Disease;
    • - Dark adaptation rod intercept < 6.5 minutes;
    • - 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) <30 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 with childbearing potential;
    • -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): NCT02873351


Locations
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United States, Arizona
Robert W Snyder, MD, PhD, PC
Tucson, Arizona, United States, 85712
Sponsors and Collaborators
Snyder, Robert W., M.D., Ph.D., P.C.
Investigators
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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

Publications:
Sinemet package insert (FDA approved).
Hongyang Zhang; Nizar Saleh Abdelfattah; David S Boyer; Srinivas R Sadda, Longitudinal Quantitative OCT Analysis of Drusen in the Fellow Eye of Patients with Unilateral Neovascular Age-Related Macular Degeneration, ARVO Annual Meeting Abstract, 2015.
Westfall, T.C. and Westfall, D.P. Drugs Acting at Synaptic and Neuroeffector Junctions. Pharmacological Basis of Therapeutics, 11th Edition, 530-535, McGraw-Hill, 2006.
Standaert, D.G. and Young, A.B. Treatment of Central Nervous System Degenerative Disorders. Pharmacological Basis of Therapeutics, 11th Edition, 530-535, McGraw-Hill, 2006.

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Responsible Party: Snyder, Robert W., M.D., Ph.D., P.C.
ClinicalTrials.gov Identifier: NCT02873351     History of Changes
Other Study ID Numbers: 0000
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: May 2017
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.:
L-DOPA
GPR143
PEDF
VEGF
Additional relevant MeSH terms:
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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