Carbidopa-Levodopa in Dry AMD With Geographic Atrophy

NCT03451500 | Terminated Phase 2 FDA Drug

• 1 other identifier: 0004
• Study Type: interventional
• Target: 7
• 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 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.

Conditions

Age Related Macular Degeneration

Keywords

GPR 143; PEDF; VEGF; LDOPA

Outcome Measures

Primary Outcomes (1)

• Area of Geographic Atrophy

  area of retinal geographic atrophy measured by fundus autofluorescence

  Change over 12 months

Secondary Outcomes (3)

• Best Corrected Visual Acuity by ETDRS

  Change over 12 months

• Central retinal thickness

  Change over 12 months

• Development of neovascular macular degeneration

  New diagnosis during 12 months of treatment

Study Arms (3)

Carbidopa-levodopa 2 tablets daily

EXPERIMENTAL

carbidopa-levodopa 25-100 mg 2 tablets daily hs

Drug: carbidopa-levodopa

carbidopa-levodopa 6 tablets daily

EXPERIMENTAL

carbidopa-levodopa 25-100 mg, 2 tablets, 3 times daily, with breakfast, with supper and hs

Drug: carbidopa-levodopa

Placebo

PLACEBO COMPARATOR

Placebo, 2 tablets, 3 times daily, with breakfast, with supper and hs

Drug: carbidopa-levodopa

Interventions

carbidopa-levodopa DRUG

See previous

Carbidopa-levodopa 2 tablets daily; Placebo; carbidopa-levodopa 6 tablets daily

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 these supplements for the duration of the study, if not taking them prior to the study;
• Signed Informed Consent.

You may not qualify if:

• 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;
• 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 20/100 in the eye with better BCVA;
• Current, or history of, neovascular AMD in either 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;

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

MeSH Terms

Conditions

Macular Degeneration

Interventions

carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Timothy C Fagan, MD

  Robert Snyder, MD, PhD, PC

  STUDY DIRECTOR

• Robert W Snyder, MD, PhD

  Robert Snyder, MD, PhD, PC

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Randomized, prospective, placebo controlled

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: March 1, 2018
• Study Start: July 1, 2018
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)