Clinical Trial: Retinal Abnormalities as Biomarker of Disease Progression and Early Diagnosis of Parkinson Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Retinal Abnormalities as Biomarker of Disease Progression and Early Diagnosis of Parkinson Disease

Brief Summary:

• To determine whether retinal abnormalities, as measured by high definition optical coherence tomography (HD-OCT) and visual electrophysiology techniques can be used as a clinical biomarker to monitor disease progression overtime in patients with Parkinson disease.
• To establish whether these measures can be used to identify patients with PD in the premotor phase.
• To define the rate of progression of retinal abnormalities in PD (both in the motor and premotor stages) for potential use as a clinical outcome measure

Detailed Summary:

The retina is actually brain tissue and is considered part of the central nervous system (CNS). It is the only part of the CNS that can be visualized directly and non-invasively. There is already a body of evidence that retinal neurons accumulate alpha-synuclein and degenerate in Parkinson disease (PD). Whether retinal imaging could be useful as an objective biomarker to track disease progression and response to disease-modifying treatments in patients with PD is not known.

While there are a variety of imaging techniques available (e.g., PET, SPECT, MRI), none of them has emerged as a fully reliable method to accurately measure clinical progression in PD.

The structure of the retina can be studied easily in vivo using spectral domain high definition optical coherence tomography (OCT), a non-invasive imaging technique with a resolution of ~1 microns (0.001 mm). OCT quantifies the thickness of the different retinal layers. The primary aim of this proposal is to determine whether OCT is a reliable clinical measure that can objectively measure clinical progression in PD.

Our group has shown recently that OCT can be used as a means to measure progressive neuronal loss in the retina in patients with a synucleinopathy closely related to PD (multiple system atrophy, MSA). In MSA, retinal degeneration was closely associated with disease severity and progressively worsened overtime in a predictable fashion, sufficient for biostatistical modeling. We now want to find out if this is also true in PD.

There is a panel of non-motor clinical features that increase the risk of developing PD. We propose to measure retinal nerve fiber density in these patients considering them as "pre-motor" PD and follow their clinical evolution ove
Sponsor: New York University School of Medicine

Current Primary Outcome:

• Retinal nerve fiber layer (RNFL) thickness [ Time Frame: Every 6 months from baseline to 3 years ]
  The results of the RNFL thickness will be expressed in microns in different zones around the optic nerve: temporal, superior, nasal, inferior and global.
• Retinal ganglion cell layer (GCL) thickness [ Time Frame: Every 6 months from baseline to 3 years ]
  The results of the GCL thickness will be expressed in microns in different zones around the fovea region: temporal- superior, superior, nasal-superior, nasal inferior, inferior, temporal inferior and global.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• • Visual Acuity [ Time Frame: Every 6 months from baseline to 3 years ]
  Will be expressed in decimal units
• • Color Discrimination [ Time Frame: Every 6 months from baseline to 3 years ]
  Will be expressed in decimal units.
• • Pupillometry [ Time Frame: Every 6 months from baseline to 3 years ]
  Measures will include pupil diameter (expressed in millimeters, in dark and light conditions and the amplitude and velocity of the pupillary response.
• • Videonystagmography [ Time Frame: Every 6 months from baseline to 3 years ]
  Saccadic velocity and amplitude (expressed in m/seg and degrees) will be measured.

Original Secondary Outcome: Same as current

Information By: New York University School of Medicine

Dates:
Date Received: December 22, 2015
Date Started: February 2016
Date Completion: January 2019
Last Updated: August 4, 2016
Last Verified: August 2016