Parkinson DiseaseNCT02640339
Retinal Abnormalities as Biomarker of Disease Progression and Early Diagnosis of Parkinson Disease
An observational study of Parkinson Disease and Multiple System Atrophy, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Multiple System Atrophy, REM Sleep Behavior Disorder
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 31 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will select patients from our clinic and take advantage of the infrastructure used in the ongoing NIH-funded Natural History of Autonomic Disorders study (ClnicalTrials.gov: NCT01799915), which prospectively follows patients with synucleinopathies with standardized neurological measures overtime.
Who may be able to join
- Subjects with PD, MSA and DLB that fulfill current diagnostic criteria.
- Subjects with RBD that have polysomnography-confirmed diagnosis showing evidence of lack of muscle atonia and dream enacting behaviors during REM sleep.
- Subjects with isolated autonomic failure (i.e., no motor deficits) that have evidence of neurogenic orthostatic hypotension and other features of autonomic failure without clinical evidence of cognitive impairment.
- Control subjects with no history of neurological or ophthalmological disorders.
Who cannot join
- Subjects with glaucoma, retinopathy, or significant media opacification (e.g., cataracts).
- Subjects with a history of eye surgery or eye trauma
- Inability to comply with the requirements of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
- 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
Read the detailed description
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 overtime. If OCT proves useful as a means to identify pre-motor PD, such a result would present an important therapeutic window to intervene with disease modifying drugs and to prevent the development of CNS deficits.
We plan to determine whether retinal morphology can be correlated with visual function using complementary measures of visual electrophysiology techniques, including pattern electroretinogram (PERG) and photopic negative response (PhNR). These techniques have been used in patients with PD and other synucleinopathies, and do map closely to retinal function abnormalities. But, there is little data describing how these functional measure of the retina progression over time in PD.
We hypothesize that patients with PD have specific patterns of damage in retinal structure and function, that this pattern can be identified in the premotor phase, We believe that OCT can be used as an objective biomarker of premotor diagnosis and disease progression.
INNOVATION:
The structure of the retina presents an ideal opportunity to image the CNS overtime with OCT. As a widely available clinical technique that correlates closely with functional measures of visual electrophysiology, OCT is being increasingly used in multiple sclerosis and other neurodegenerative disorders. If successful, this work may provide a significant tool for the diagnosis of PD in the pre-motor phase and could be used as a clinical outcome measure in disease-modifying trials. To achieve these objectives, we will take advantage of the infrastructure used in the ongoing NIH-funded Natural History of Autonomic Disorders study (ClnicalTrials.gov: NCT01799915), which prospectively follows patients with synucleinopathies with standardized neurological measures overtime. The proposal will provide measures of retinal structure in conjunction with measures of disease severity in a group of patients with well-defined PD. By measuring retinal structure in a group of patients considered high risk for developing PD (namely REM sleep behavior disorder -RBD, and isolated autonomic failure) we will determine the usefulness of OCT as a mean to identify PD in the premotor phase.
- Conditions
- Parkinson Disease, Multiple System Atrophy, REM Sleep Behavior Disorder, Pure Autonomic Failure, Dementia With Lewy Bodies
- Medical subject headings
- Parkinson Disease, Multiple System Atrophy, REM Sleep Behavior Disorder, Pure Autonomic Failure, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson Disease | Parkinson's disease is a progressive disorder of the nervous system that affects movement. It develops gradually, with alpha-synuclein deposits in neurons which aggregate into Lewy bodies. | |
| Mutiple system atrophy | is a degenerative neurological disorder. MSA is associated with the degeneration of nerve cells in specific areas of the brain. This cell degeneration causes problems with movement, balance, and autonomic functions of the body such as bladder control or blood-pressure regulation. Neuronal death probably occurs as a consequence of alpha-synuclein aggregation in oligodendroglia. | |
| REM sleep behavior disorder | a sleep disorder in which you physically act out vivid, often unpleasant dreams with vocal sounds and sudden, often violent arm and leg movements | |
| dementia with Lewy bodies | causes a progressive decline in mental abilities. It may also cause visual hallucinations, which generally take the form of objects, people or animals that aren't there. This can lead to unusual behavior such as having conversations with deceased loved ones. Another indicator of Lewy body dementia may be significant fluctuations in alertness and attention, which may include daytime drowsiness or periods of staring into space. And, like Parkinson's disease, Lewy body dementia can result in rigid muscles, slowed movement and tremors. | |
| Pure autonomic failure | Pure autonomic failure is dysfunction of many of the processes controlled by the autonomic nervous system, such as control of blood pressure•Blood pressure may decrease when people stand, and they may sweat less and may have eye problems, retain urine, become constipated, or lose control of bowel movements | |
| Healthy controls | Healthy normals with no neurological involvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal nerve fiber layer (RNFL) thickness
The results of the RNFL thickness will be expressed in microns in different zones around the optic nerve: temporal, superior, nasal, inferior and global.
Measured: Every 6 months from baseline to 3 years
Retinal ganglion cell layer (GCL) thickness
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.
Measured: Every 6 months from baseline to 3 years
Secondary outcomes (4)
• Visual Acuity
Will be expressed in decimal units
Measured: Every 6 months from baseline to 3 years
• Color Discrimination
Will be expressed in decimal units.
Measured: Every 6 months from baseline to 3 years
• Pupillometry
Measures will include pupil diameter (expressed in millimeters, in dark and light conditions and the amplitude and velocity of the pupillary response.
Measured: Every 6 months from baseline to 3 years
• Videonystagmography
Saccadic velocity and amplitude (expressed in m/seg and degrees) will be measured.
Measured: Every 6 months from baseline to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionSep 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Sponsor
- Investigators
- Horacio C Kaufmann, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640339
- Sponsor's protocol ID
- 15-01391
- Status last verified
- Dec 2020
- First submitted
- 22 Dec 2015
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Abnormalities as Biomarker of Disease Progression and Early Diagnosis of Parkinson Disease
- ClinicalTrials.gov ID
- NCT02640339
- Acronym / sponsor ID
- 15-01391
- Conditions
- Parkinson Disease, Multiple System Atrophy, REM Sleep Behavior Disorder, Pure Autonomic Failure, Dementia With Lewy Bodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- Feb 2016
- Primary completion
- Sep 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 28 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 description
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 overtime. If OCT proves useful as a means to identify pre-motor PD, such a result would present an important therapeutic window to intervene with disease modifying drugs and to prevent the development of CNS deficits.
We plan to determine whether retinal morphology can be correlated with visual function using complementary measures of visual electrophysiology techniques, including pattern electroretinogram (PERG) and photopic negative response (PhNR). These techniques have been used in patients with PD and other synucleinopathies, and do map closely to retinal function abnormalities. But, there is little data describing how these functional measure of the retina progression over time in PD.
We hypothesize that patients with PD have specific patterns of damage in retinal structure and function, that this pattern can be identified in the premotor phase, We believe that OCT can be used as an objective biomarker of premotor diagnosis and disease progression.
INNOVATION:
The structure of the retina presents an ideal opportunity to image the CNS overtime with OCT. As a widely available clinical technique that correlates closely with functional measures of visual electrophysiology, OCT is being increasingly used in multiple sclerosis and other neurodegenerative disorders. If successful, this work may provide a significant tool for the diagnosis of PD in the pre-motor phase and could be used as a clinical outcome measure in disease-modifying trials. To achieve these objectives, we will take advantage of the infrastructure used in the ongoing NIH-funded Natural History of Autonomic Disorders study (ClnicalTrials.gov: NCT01799915), which prospectively follows patients with synucleinopathies with standardized neurological measures overtime. The proposal will provide measures of retinal structure in conjunction with measures of disease severity in a group of patients with well-defined PD. By measuring retinal structure in a group of patients considered high risk for developing PD (namely REM sleep behavior disorder -RBD, and isolated autonomic failure) we will determine the usefulness of OCT as a mean to identify PD in the premotor phase.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Parkinson Disease | – | –Parkinson's disease is a progressive disorder of the nervous system that affects movement. It develops gradually, with alpha-synuclein deposits in neurons which aggregate into Lewy bodies. |
| Mutiple system atrophy | – | –is a degenerative neurological disorder. MSA is associated with the degeneration of nerve cells in specific areas of the brain. This cell degeneration causes problems with movement, balance, and autonomic functions of the body such as bladder control or blood-pressure regulation. Neuronal death probably occurs as a consequence of alpha-synuclein aggregation in oligodendroglia. |
| REM sleep behavior disorder | – | –a sleep disorder in which you physically act out vivid, often unpleasant dreams with vocal sounds and sudden, often violent arm and leg movements |
| dementia with Lewy bodies | – | –causes a progressive decline in mental abilities. It may also cause visual hallucinations, which generally take the form of objects, people or animals that aren't there. This can lead to unusual behavior such as having conversations with deceased loved ones. Another indicator of Lewy body dementia may be significant fluctuations in alertness and attention, which may include daytime drowsiness or periods of staring into space. And, like Parkinson's disease, Lewy body dementia can result in rigid muscles, slowed movement and tremors. |
| Pure autonomic failure | – | –Pure autonomic failure is dysfunction of many of the processes controlled by the autonomic nervous system, such as control of blood pressure•Blood pressure may decrease when people stand, and they may sweat less and may have eye problems, retain urine, become constipated, or lose control of bowel movements |
| Healthy controls | – | –Healthy normals with no neurological involvement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will select patients from our clinic and take advantage of the infrastructure used in the ongoing NIH-funded Natural History of Autonomic Disorders study (ClnicalTrials.gov: NCT01799915), which prospectively follows patients with synucleinopathies with standardized neurological measures overtime.
Key inclusion criteria (4 listed)
- Subjects with PD, MSA and DLB that fulfill current diagnostic criteria.
- Subjects with RBD that have polysomnography-confirmed diagnosis showing evidence of lack of muscle atonia and dream enacting behaviors during REM sleep.
- Subjects with isolated autonomic failure (i.e., no motor deficits) that have evidence of neurogenic orthostatic hypotension and other features of autonomic failure without clinical evidence of cognitive impairment.
- Control subjects with no history of neurological or ophthalmological disorders.
Key exclusion criteria (3 listed)
- Subjects with glaucoma, retinopathy, or significant media opacification (e.g., cataracts).
- Subjects with a history of eye surgery or eye trauma
- Inability to comply with the requirements of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
4 secondary outcomes
• Visual Acuity
Time frame: Every 6 months from baseline to 3 years
• Color Discrimination
Time frame: Every 6 months from baseline to 3 years
• Pupillometry
Time frame: Every 6 months from baseline to 3 years
• Videonystagmography
Time frame: Every 6 months from baseline to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Horacio C Kaufmann, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Multiple System Atrophy, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal nerve fiber layer (RNFL) thickness (time frame: Every 6 months from baseline to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.