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

NCT02873351 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 0000
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-related Macular Degeneration

Keywords

L-DOPA; GPR143; PEDF; VEGF

Outcome Measures

Primary Outcomes (1)

• Treatment Emergent Adverse Events

  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.

  90 +- 10 days

Secondary Outcomes (5)

• Change from Baseline in Best Corrected Visual Acuity

  45 +/- 5 days and 90 +/- 10 days

• Change from Baseline in Low Light Visual Acuity

  45 +/- 5 days and 90 +/- 10 days

• Change from Baseline in Dark Adaptation

  45 +/- 5 days and 90 +/- 10 days

• Change from Baseline in Low Luminance Questionnaire Scores

  45 +/- 5 days and 90 +/- 10 days

• Change from Baseline in Optical Coherence Tomography

  45 +/- 5 days and 90 +/- 10 days

Study Arms (2)

carbidopa-levodopa 25-100 mg

EXPERIMENTAL

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

Placebo for carbidopa-levodopa 25-100 mg

PLACEBO COMPARATOR

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

Interventions

carbidopa-levodopa 25-100 mg DRUG

included in arm description

carbidopa-levodopa 25-100 mg

placebo for carbidopa-levodopa 25-100 mg DRUG

included in arm description

Placebo for carbidopa-levodopa 25-100 mg

Eligibility Criteria

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

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

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

Study Sites (1)

Robert W Snyder, MD, PhD, PC

Tucson, Arizona, 85712, United States

Location

Related Publications (18)

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  BACKGROUND

MeSH Terms

Conditions

Macular Degeneration

Interventions

carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Robert W Snyder, MD, PhD

  Robert W Snyder, MD, PhD, PC

  PRINCIPAL INVESTIGATOR

• Timothy C Fagan, MD

  Robert W Snyder, MD, PhD, PC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 19, 2016
• Study Start: September 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 5, 2019

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)