Retinal Imaging for Neurodegenerative Disease

Overseen By Sharon Fekrat, MD FACS FASRS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Duke University

Disqualifiers: Inability to cooperate, Intraocular surgery, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial uses special cameras to take detailed pictures of the back of the eye in people with cognitive impairments or neurodegenerative diseases. Researchers analyze these images to find early signs of these diseases by examining tiny blood vessels in the eye.

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 data supports the effectiveness of the treatment Retinal Imaging, Optical Coherence Tomography (OCT), OCT Angiography (OCTA), Ultra-Widefield (UWF) Fundus Photography for neurodegenerative diseases?

Research shows that OCT and OCTA can provide detailed images of the retina, which can help detect changes related to neurodegenerative diseases like Alzheimer's and Parkinson's. These imaging techniques are non-invasive and can serve as markers for early diagnosis and monitoring of these conditions. ^{1 2 3 4 5}

Is retinal imaging safe for humans?

Retinal imaging techniques like OCT and OCTA are generally considered safe as they are non-invasive, meaning they don't require surgery or entering the body, and are used widely in diagnosing eye and systemic diseases. ^{1 6 7 8 9}

How is retinal imaging used as a treatment for neurodegenerative diseases different from other treatments?

Retinal imaging for neurodegenerative diseases is unique because it is a non-invasive method that uses advanced technologies like optical coherence tomography (OCT) to detect and monitor disease-specific changes in the retina, which is an extension of the brain. This approach offers high-resolution imaging and is more accessible and cost-effective compared to traditional brain imaging techniques like MRI, making it a promising tool for early detection and monitoring of diseases like Alzheimer's and Parkinson's. ^{1 4 10 11 12}

Research Team

Sharon Fekrat, MD FACS FASRS

Principal Investigator

Duke University

Dilraj Grewal, MD

Principal Investigator

Duke University

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Retinal Imaging (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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Optical coherence tomography angiography in neuronal diseases : Preliminary findings]. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Optical Coherence Tomography Angiography in Neurodegenerative Disorders. [2020]

3. France pubmed.ncbi.nlm.nih.gov

[New retinal imaging techniques]. [2016]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Pushing Retinal Imaging Forward: Innovations and Their Clinical Meaning - The 2022 Ophthalmologica Lecture. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Optical coherence tomography in the investigation of systemic neurologic disease. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Optical Coherence Tomography Angiography of Mixed Neovascularizations in Age-Related Macular Degeneration. [2016]

7. Germany pubmed.ncbi.nlm.nih.gov

OCT Angiography as an Interdisciplinary Diagnostic Tool for Systemic Diseases. [2021]

8. France pubmed.ncbi.nlm.nih.gov

[Indications for fluorescein angiography and optical coherence tomography angiography (OCTA) in medical retina: Changes from 2015 and 2018]. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of Diabetic Retinopathy Lesions Identified Using Ultrawide Field Imaging and Optical Coherence Tomography Angiography. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Optical Coherence Tomography in Alzheimer's Disease and Other Neurodegenerative Diseases. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Retinal imaging in Alzheimer's disease. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Past, present and future role of retinal imaging in neurodegenerative disease. [2023]