Retinal Imaging for Neurodegenerative Disease

Overseen By Sharon Fekrat, MD FACS FASRS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Inability to cooperate, Intraocular surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how eye imaging might help identify neurodegenerative diseases like Alzheimer's and Parkinson's. By using non-invasive techniques such as Retinal Imaging—including Optical Coherence Tomography, OCT Angiography, and Ultra-Widefield Fundus Photography—to examine the retina and its blood vessels, researchers aim to find new markers that signal these diseases early. The study seeks participants with mild cognitive problems, any neurodegenerative condition, or healthy brains.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to earlier detection of neurodegenerative diseases.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that retinal imaging is safe for assessing neurodegenerative diseases?

Research has shown that retinal imaging methods like OCT and OCTA are safe and non-invasive. Studies have found that patients tolerate these procedures well, with no major side effects reported. OCT and OCTA allow doctors to view the small blood vessels and structures in the eye without causing discomfort or risk. This makes retinal imaging a promising tool for studying brain diseases like Alzheimer's and Parkinson's. Overall, current evidence supports the strong safety of retinal imaging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about retinal imaging for neurodegenerative diseases because it offers a non-invasive way to potentially detect diseases like Alzheimer's, Parkinson's, and multiple sclerosis early on. Unlike traditional methods such as MRI or PET scans, which can be costly and time-consuming, retinal imaging is quicker and might be more accessible. This technique could revolutionize early diagnosis and allow for interventions to start sooner, potentially slowing disease progression.

What evidence suggests that retinal imaging is effective for assessing neurodegenerative diseases?

This trial will use retinal imaging techniques, including Optical Coherence Tomography (OCT) and OCT Angiography (OCTA), to explore their potential in detecting early signs of neurodegenerative diseases. Research has shown that examining the retina, the back part of the eye, can help identify early indicators of brain diseases like Alzheimer's and Parkinson's. Studies have found that these special eye scans can spot changes early. Additionally, using artificial intelligence (AI) with these eye scans has been fairly accurate in diagnosing these conditions, achieving a score of about 0.726 out of 1. New imaging methods might further enhance the detection of early signs of diseases like Alzheimer's. Overall, checking the retina offers a promising, simple, and affordable way to screen for brain diseases. ^{1 3 4 6 7}

Who Is on the Research Team?

Sharon Fekrat, MD FACS FASRS

Principal Investigator

Duke University

Dilraj Grewal, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults with or without neurodegenerative diseases like Alzheimer's, Parkinson's, Multiple Sclerosis, and others. It includes those with mild cognitive issues or traumatic brain injuries. People can't join if they've had certain eye surgeries (except cataract surgery) or have conditions that make it hard to get clear images of their eyes.

Inclusion Criteria

I have a neurodegenerative condition like Alzheimer's or Parkinson's.

Adults who do not have a brain disease that gets worse over time.

I have a neurodegenerative condition like Alzheimer's, Parkinson's, or MS.

Exclusion Criteria

You have trouble following instructions or completing tests, or you have certain neurological or eye conditions that could affect taking pictures.

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

I have had eye surgery, but not for cataracts.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial imaging and assessment using OCT, OCTA, and UWF fundus photography to establish baseline measurements

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in retinal and choroidal biomarkers over time

1 year

Multiple visits (in-person) over the year

What Are the Treatments Tested in This Trial?

Interventions

• Retinal Imaging

Trial Overview The study tests non-invasive imaging techniques to examine the retina and choroid in the eye. These include optical coherence tomography (OCT), OCT angiography (OCTA), and ultra-widefield fundus photography to find biomarkers for various neurodegenerative diseases.

How Is the Trial Designed?

Group I: Controls Experimental Treatment 1 Intervention

Controls will be recruited from the relatives/attendants of study participants or will be patients themselves and will not have a neurodegenerative disease diagnosis.

Group II: Case Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

University of Edinburgh

Collaborator

Trials

484

Recruited

17,160,000+

Tan Tock Seng Hospital in Singapore

Collaborator

Trials

1

Recruited

2,000+

Queens University of Belfast United Kingdom

Collaborator

Trials

1

Recruited

2,000+

University of Edinburgh in Scotland

Collaborator

Trials

1

Recruited

2,000+

Published Research Related to This Trial

Optical coherence tomography angiography (OCT-A) is a non-invasive imaging technique that can visualize blood flow in the retina, making it a potential tool for detecting microvascular damage associated with neurodegenerative disorders.

Current literature suggests that OCT-A may help in diagnosing and monitoring conditions like glaucoma, Alzheimer's disease, Parkinson's disease, and multiple sclerosis, highlighting its potential as an early biomarker for these diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical Coherence Tomography Angiography in Neurodegenerative Disorders. Pellegrini, M., Vagge, A., Ferro Desideri, LF., et al.[2020]

Retinal imaging technologies, such as optical coherence tomography (OCT), provide rapid, non-invasive insights into retinal structure and function, significantly enhancing the understanding and management of retinal diseases.

These imaging modalities are also being explored for their potential in diagnosing and monitoring neurodegenerative diseases like Alzheimer's and Parkinson's, offering a cost-effective alternative to traditional brain imaging techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Past, present and future role of retinal imaging in neurodegenerative disease. Kashani, AH., Asanad, S., Chan, JW., et al.[2023]

Optical coherence tomography angiography (OCTA) can noninvasively image and measure changes in retinal structures associated with neuronal diseases, such as Alzheimer's, Parkinson's, and multiple sclerosis.

The study found that these diseases are linked to a reduction in retinal vessel density and atrophy of retinal layers, suggesting that OCTA parameters could serve as valuable biomarkers for assessing neurovascular health in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Optical coherence tomography angiography in neuronal diseases : Preliminary findings]. Mardin, CY., Hosari, S.[2020]

OCT angiography (OCT-A) is a non-invasive imaging technique that provides detailed visualization of retinal blood circulation, which is crucial for diagnosing eye disorders and systemic diseases that may affect the eyes.

This review highlights the growing importance of OCT-A in clinical practice, emphasizing its ability to observe retinal circulation at a micrometre scale, enhancing our understanding of various ocular conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OCT Angiography as an Interdisciplinary Diagnostic Tool for Systemic Diseases. Hohberger, B., Mardin, CY.[2021]

The retina shows early signs of neurodegenerative diseases like Alzheimer's and Parkinson's, including the presence of amyloid β-protein plaques and significant structural changes, which can be detected through advanced imaging techniques.

Optical coherence tomography (OCT) is a powerful noninvasive tool that allows for high-resolution imaging of the retina, helping to identify and monitor these pathological changes, making it useful for assessing disease progression and treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical Coherence Tomography in Alzheimer's Disease and Other Neurodegenerative Diseases. Doustar, J., Torbati, T., Black, KL., et al.[2020]

Non-invasive retinal imaging technologies, such as optical coherence tomography (OCT), have shown promise in identifying biomarkers for Alzheimer's disease (AD) by revealing structural changes in the retina that correlate with cognitive impairment.

Quantitative measurements from these imaging techniques, like retinal nerve fiber layer thinning and reduced capillary density, can aid in the early detection and screening of AD, potentially leading to better risk stratification and therapeutic development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retinal imaging in Alzheimer's disease. Cheung, CY., Mok, V., Foster, PJ., et al.[2022]

In a study of 114 eyes from 57 diabetic patients, findings from ultrawide field fluorescein angiography (UWF-FA) were strongly correlated with the severity of diabetic retinopathy (DR) and the presence of diabetic macular edema (DME), indicating that UWF-FA can be a valuable tool for assessing these conditions.

Optical coherence tomography angiography (OCTA) metrics, such as vessel density and perfusion in the superficial capillary plexus, were also linked to DME and macular ischemia, suggesting that OCTA can provide important insights into the vascular health of diabetic eyes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Diabetic Retinopathy Lesions Identified Using Ultrawide Field Imaging and Optical Coherence Tomography Angiography. Salongcay, RP., Aquino, LAC., Salva, CMG., et al.[2023]

Optical coherence tomography angiography has enhanced our understanding of the choroid's role in age-related macular degeneration (AMD), providing insights into its pathology.

The article discusses the 'postreceptor neuronal loss' theory in AMD, supported by structural OCT findings, and highlights the application of OCT in diagnosing various retinal and optic nerve diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pushing Retinal Imaging Forward: Innovations and Their Clinical Meaning - The 2022 Ophthalmologica Lecture. Borrelli, E., Berni, A., Mastropasqua, L., et al.[2023]

Retinal imaging techniques, including fundus photography and optical coherence tomography (OCT), are essential for diagnosing macular diseases, often used in combination for more accurate results.

New methods like wide-field retinography and adaptive optics enhance the ability to visualize retinal structures, improving the screening and diagnosis of conditions like diabetic retinopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New retinal imaging techniques]. Gaudric, A.[2016]

Optical coherence tomography angiography (OCTA) is effective in identifying mixed neovascularization in age-related macular degeneration (AMD), providing detailed imaging of neovascular vessels.

The study highlights that OCTA can visualize neovascular vessels both below and above the retinal pigment epithelium, correlating with leakage patterns seen in traditional angiography methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical Coherence Tomography Angiography of Mixed Neovascularizations in Age-Related Macular Degeneration. Liang, MC., Witkin, AJ.[2016]

Optical coherence tomography (OCT) is a valuable tool not only for diagnosing and monitoring eye diseases but also for assessing systemic neurodegenerative disorders like Parkinson's, Alzheimer's, and multiple sclerosis.

OCT-derived retinal measures can provide important insights into the severity and progression of these systemic conditions, highlighting its potential as a non-invasive diagnostic marker.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical coherence tomography in the investigation of systemic neurologic disease. Srinivasan, S., Efron, N.[2020]

In a study of 651 patients with retinal disorders, optical coherence tomography angiography (OCTA) was used in 49.4% of cases, significantly reducing the need for fluorescein angiography (FA) to just 6.5%, which dropped to 2% after the first year of OCTA implementation.

The primary reasons for using OCTA included age-related macular degeneration (AMD) in 50% of cases, while FA was mainly used for diabetic retinopathy (DR), indicating that OCTA is becoming the preferred method for diagnosing and managing retinal diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Indications for fluorescein angiography and optical coherence tomography angiography (OCTA) in medical retina: Changes from 2015 and 2018]. Le Rouic, JF., Peronnet, P., Barrucand, A., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03233646

Retinal Imaging in Neurodegenerative Disease This study aims to develop and evaluate biomarkers using non-invasive optical coherence tomography (OCT) and OCT angiography (OCTA) as well as ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8280255/

Past, present and future role of retinal imaging in ... The notion that neurodegenerative changes in the brain are present in the retina is supported by extensive evidence from in vivo retinal imaging studies.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1572100025003199

Retinal imaging and artificial intelligence: A systematic ... Artificial intelligence (AI) applied to retinal imaging demonstrates moderate diagnostic accuracy (AUC = 0.726) for neurodegenerative diseases like ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/mef2.70034

Retinal Imaging Techniques for Neurodegenerative ... Considering the economic and wide applicability, retinal image techniques are potential tools to screen PD and even other neurodegenerative ...

5. nature.com nature.com/articles/s41746-024-01292-5

Early detection of dementia through retinal imaging and ... We propose a novel deep learning framework, Eye-AD, to detect Early-onset Alzheimer's Disease (EOAD) and Mild Cognitive Impairment (MCI) using OCTA images.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7368556/

Optical Coherence Tomography Angiography in ... OCT-A has emerged as a novel, fast, safe and non-invasive imaging technique of analyzing the retinal and choroidal microvasculature in vivo.

7. medrxiv.org medrxiv.org/content/10.1101/2024.05.27.24306765v1.full.pdf

Using Retinal diagnostics as a Biomarker for ... Structural retinal measures derived from optical coherence tomography (OCT) imaging have been shown to differ in established AD and PD, with ...