Retinal Imaging in Neurodegenerative Disease

Multiple Sclerosis Clinical Trial

Official title:

Evaluating the Retinal and Choroidal Microvasculature and Structure Using Multimodal Retinal and Choroidal Imaging in Neurodegenerative Disease: iMIND Research Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03233646
• Other study ID #: Pro00111831
• Status: Recruiting
• Start date: July 20, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: Sharon Fekrat, MD FACS FASRS
• Phone: 919-681-3937
• Email: imind[@]duke.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to develop and evaluate biomarkers using non-invasive optical coherence tomography (OCT) and OCT angiography (OCTA) as well as ultra-widefield (UWF) fundus photography to assess the structure and function of the retinal and choroidal microvasculature and structure in persons with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), Parkinson's Disease (PD), or other neurodegenerative disease, diseases as outlined.

Description:

Using a multidisciplinary approach, this study aims to yield new insight into the vascular and structural pathophysiology of neurodegenerative disease. The investigators propose to develop and evaluate imaging biomarkers from OCT, OCTA, and UWF fundus photos to assess the structure and function of the retinal and choroidal microvasculature and structure in these individuals.

The investigators hypothesize that microvascular and structural network alterations in the retina and choroid may mirror and possibly precede changes in the cerebral microcirculation seen in these neurodegenerative diseases. Using advanced image analysis and machine learning techniques, the investigators aim to evaluate markers of reduced capillary blood flow and non-perfusion in the superficial retinal vascular plexus and choriocapillaris imaged using OCT and OCTA, in a resolution not previously possible, that would complement already established retinal structural markers and increase their sensitivity and specificity in the earlier detection of these neurodegenerative diseases.

This study looks to provide a proof of concept for retinal and choroidal imaging-based microvascular and structural biomarkers as an effective screening tool for neurodegenerative disease, particularly during in cognitive aging.

The protocol for this study was amended and the record was updated accordingly.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults with neurodegenerative disease ((MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome)

• Adults without neurodegenerative disease

Exclusion Criteria:

• Inability to cooperate with or complete testing or other neurologic or age- related ocular conditions that would impact image acquisition.

• Eyes that have had intraocular surgery, other than cataract surgery.

If two eyes satisfy the inclusion criteria, both eyes will be included in the study. If one eye satisfies the inclusion criteria, the eye that qualifies will be included in the study.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Amyotrophic Lateral Sclerosis
• Amyotrophic Lateral Sclerosis (ALS)
• Aphasia, Primary Progressive
• Brain Injuries
• Brain Injuries, Traumatic
• Cognitive Dysfunction
• Concussion
• Dementia
• Down Syndrome
• Frontotemporal Dementia
• Huntington Disease
• Lewy Body Dementia
• Lewy Body Disease
• Mild Cognitive Impairment
• Motor Neuron Disease
• Multiple Sclerosis
• Neuro-Degenerative Disease
• Neurodegenerative Diseases
• Normal Cognition
• Parkinson Disease
• Parkinson's Disease
• Pick Disease of the Brain
• Post-Traumatic Stress Disorder
• Sclerosis
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Traumatic Brain Injury

Intervention

Device:
• Retinal and Choroidal Imaging
Non-invasive OCT, OCTA, and UWF fundus photography of retina

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	Queens University of Belfast United Kingdom, Tan Tock Seng Hospital in Singapore, University of Edinburgh in Scotland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ganglion cell-inner plexiform layer (GCIPL) thickness	Ganglion cell inner plexiform layer thickness as measured on optical coherence tomography scan of macula	Baseline, 1 year
Primary	Change in retinal nerve fiber layer (RNFL) thickness	Retinal nerve fiber layer thickness as measured on optical coherence tomography scan of macula	Baseline, 1 year
Primary	Change in central subfield thickness (CST)	Central subfield thickness as measured on optical coherence tomography scan of macula	Baseline, 1 year
Primary	Change in choroidal vascularity index (CVI)	Choroidal vascularity index as measured using the COIN software in 1500 um area centered on the fovea	Baseline, 1 year
Primary	Change in foveal avascular zone (FAZ) area	Foveal avascular zone area as measured in the superficial capillary plexus on 3mm optical coherence tomography angiography scan of the macula	Baseline, 1 year
Primary	Change in average perfusion density (PD)	Average perfusion density as measured in the ETDRS 3mm and 6mm circle and rings on optical coherence tomography angiography scan of the macula	Baseline, 1 year
Primary	Change in average vessel density (VD)	Average vessel density as measured in the ETDRS 3mm and 6mm circle and rings on optical coherence tomography angiography scan of the macula	Baseline, 1 year
Primary	Change in average capillary perfusion density (CPD)	Capillary perfusion density as measured on peripapillary 4.5mm optical coherence tomography angiography scan	Baseline, 1 year
Primary	Change in average capillary flux index (CFI)	Capillary flux index as measured on peripapillary 4.5mm optical coherence tomography angiography scan	Baseline, 1 year
Secondary	Change in retinal vessel tortuosity	Retinal vessel tortuosity measured on ultra-widefield scanning laser ophthalmoscopy image using VAMPIRE software	Baseline, 1 year
Secondary	Change in retinal vessel width gradient	Retinal vessel width gradient measured on ultra-widefield scanning laser ophthalmoscopy image using VAMPIRE software	Baseline, 1 year
Secondary	Change in retinal vessel fractal dimension	Retinal vessel fractal dimension measured on ultra-widefield scanning laser ophthalmoscopy image using VAMPIRE software	Baseline, 1 year