OcuMet Beacon for Age-Related Macular Degeneration

(FPF in AMD Trial)

Overseen By Angie Adler

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Neovascular AMD, Media opacity, 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: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging technique to detect early signs of age-related macular degeneration (AMD). The goal is to determine if images from the OcuMet Beacon system (also known as Flavoprotein Fluorescence Imaging or FPF Imaging) can identify problem areas in the retina before symptoms appear. It targets individuals aged 50 or older with a confirmed diagnosis of geographic atrophy, a form of AMD. Participants will undergo special eye scans to detect patterns that might indicate worsening conditions. Those with AMD who can undergo eye imaging may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in early detection methods for AMD.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the OcuMet Beacon system is safe for retinal imaging?

Research shows that FPF imaging, such as that used by the OcuMet Beacon system, is generally safe. Studies have found this imaging method to be non-invasive, meaning it doesn't involve surgery or entering the body. The FDA has approved the OcuMet Beacon device, indicating it meets safety standards for assessing eye health.

The device detects specific light from the eyes, revealing stress in the retina. Studies reviewed have not linked this process to harmful side effects. It appears well-tolerated by patients, similar to a regular eye exam. All available evidence suggests this type of imaging is safe and causes no more discomfort than a standard eye check-up. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about FPF Imaging for age-related macular degeneration because it offers a novel approach to monitoring this condition through fundus autofluorescence (FAF) imaging. Unlike traditional treatments that focus on slowing the progression with medication or injections, FAF imaging provides a non-invasive way to visualize and track changes in the retina's health over time. This method could lead to earlier detection of disease progression and more personalized treatment plans, potentially improving outcomes for patients.

What evidence suggests that FPF Imaging is effective for age-related macular degeneration?

Research has shown that flavoprotein fluorescence (FPF), a special type of imaging that participants in this trial will receive, might help detect eye diseases like age-related macular degeneration. Studies have found that FPF can highlight areas in the retina where cells are under stress, indicating early signs of disease. One study discovered that eyes with certain conditions had much higher FPF levels than healthy eyes. This suggests FPF imaging could identify potential problems before symptoms develop. Overall, early research indicates that FPF imaging could effectively spot retinal issues early on. ^{1 5 6 7 8}

Who Is on the Research Team?

Mihai Mititelu, MD, MPH

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for individuals with Age-Related Macular Degeneration (AMD), a condition affecting the retina. It's designed to see if stressed cells in the retina show up in specific imaging before symptoms appear or the disease progresses.

Inclusion Criteria

Willing to participate as evidenced by signing the written informed consent

I am 50 years old or older.

I have been diagnosed with geographic atrophy due to age-related macular degeneration.

Exclusion Criteria

Presence of significant media opacity preventing adequate retinal imaging

Unable to tolerate ophthalmic imaging

I have an eye condition that could affect vision tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo FPF imaging using the OcuMet Beacon system and FAF imaging using Heidelberg Spectralis

Up to 45 minutes

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FPF Imaging

Trial Overview The study tests how well FPF imaging using OcuMet Beacon can detect areas of retinal cell stress and potential early signs of AMD progression, compared to standard imaging techniques.

How Is the Trial Designed?

Group I: Fundus autofluorescence (FAF) imaging Experimental Treatment 1 Intervention

FPF Imaging is already approved in United States, European Union for the following indications:

Approved in United States as FPF Imaging for:

• Diagnostic tool for age-related macular degeneration

Approved in European Union as FPF Imaging for:

• Diagnostic tool for age-related macular degeneration

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Published Research Related to This Trial

In a study of six nonexudative eyes with age-related macular degeneration (AMD), increased flavoprotein fluorescence (FPF) was detected, indicating significant mitochondrial dysfunction compared to age-matched control eyes.

All three eyes with geographic atrophy (GA) showed notable FPF heterogeneity, suggesting that variability in mitochondrial dysfunction is more pronounced in advanced stages of AMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive imaging of mitochondrial dysfunction in dry age-related macular degeneration. Field, MG., Comer, GM., Kawaji, T., et al.[2012]

In a study involving 30 patients with age-related macular degeneration (AMD), the new imaging technique, topographic angiography (TAG), was effective in visualizing neovascular structures and fluid configurations in fibrovascular pigment epithelial detachments (fPED) and serous pigment epithelial detachments (sPED).

Optical coherence tomography (OCT) provided detailed structural information about the retina and was more efficient than retinal thickness analyzer (RTA) in detecting AMD-related pathologies, although both OCT and RTA struggled with certain structural abnormalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional imaging of pigment epithelial detachment in age-related macular degeneration using optical coherence tomography, retinal thickness analysis and topographic angiography. Ahlers, C., Michels, S., Beckendorf, A., et al.[2018]

The fluorescence lifetime mapper (FLM) effectively detects early metabolic changes in age-related macular degeneration (AMD) by measuring fluorescence lifetimes in the fundus, showing significant differences between healthy individuals and AMD patients.

In AMD patients, particularly in the early stages, longer fluorescence lifetimes were observed, suggesting alterations in cellular metabolism, potentially linked to increased protein-bound NADH, which indicates reduced cellular respiration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of parameters of time-resolved autofluorescence between healthy subjects and patients suffering from early AMD]. Schweitzer, D., Quick, S., Schenke, S., et al.[2021]

The study focuses on developing a fluorescent imaging system to detect amyloid-β (Aβ) proteins in the retina, which could help in diagnosing Alzheimer disease, affecting over 5 million people in the U.S.

Initial tests using imaging probes like Cy5 and CRANAD-2 show promise for this system, indicating its potential as a tool for studying Aβ as a biomarker for Alzheimer's, with further performance evaluations planned.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Optimization of a Fluorescent Imaging System to Detect Amyloid-β Proteins: Phantom Study. Tes, D., Kratkiewicz, K., Aber, A., et al.[2020]

A new digital image analysis method using scanning laser ophthalmoscopy allows for reliable quantification of hyperfluorescence in fluorescein angiograms, improving the assessment of age-related macular degeneration (AMD).

In a study of 86 angiograms, the method effectively categorized different forms of AMD, revealing distinct fluorescence patterns for subretinal neovascularization and pigment epithelial detachment, which could enhance diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new method of image analysis of fluorescein angiography applied to age-related macular degeneration. Saito, J., Roxburgh, ST., Sutton, D., et al.[2009]

In a study of 53 patients with intermediate age-related macular degeneration, 228 drusen were analyzed, revealing a correlation between drusen morphology and their autofluorescence characteristics, which may indicate different stages of disease progression.

The findings suggest that the status of outer retinal layers, such as the external limiting membrane and ellipsoid zone, also correlates with autofluorescence, highlighting the potential for these imaging techniques to serve as biomarkers for monitoring nonexudative age-related macular degeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CORRELATION STUDY BETWEEN DRUSEN MORPHOLOGY AND FUNDUS AUTOFLUORESCENCE. Flores, R., Carneiro, A., Serra, J., et al.[2021]

In a study of 25 eyes from 18 patients with late age-related macular degeneration (AMD), 56% of the eyes showed the presence of green emission fluorescence component (GEFC) in the macular atrophy area, indicating the presence of short-wave fluorophores.

The presence of GEFC correlated with hyper-reflective material on optical coherence tomography (OCT) scans, suggesting that these fluorophores may be linked to residual debris or drusenoid material in the affected areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Green emission fluorophores in eyes with atrophic age-related macular degeneration: a colour fundus autofluorescence pilot study. Borrelli, E., Lei, J., Balasubramanian, S., et al.[2019]

In a study of a 69-year-old man with early age-related macular degeneration, basal linear deposit (BLinD) was found to cover significantly more area of the retina (40% to 46%) compared to drusen (21% to 14%), indicating that BLinD may play a critical role in disease progression.

The research highlights the importance of improved imaging techniques for better visualization of BLinD, which could enhance early detection and monitoring of age-related macular degeneration, ultimately aiding in patient management and clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ABUNDANCE AND MULTIMODAL VISIBILITY OF SOFT DRUSEN IN EARLY AGE-RELATED MACULAR DEGENERATION: A Clinicopathologic Correlation. Chen, L., Messinger, JD., Sloan, KR., et al.[2023]

In a study involving three male patients with unilateral central serous retinopathy, the affected eyes showed significantly higher retinal flavoprotein fluorescence (FPF) compared to their unaffected eyes.

The FPF in eyes with central serous retinopathy was, on average, 98% greater than that of age-matched control eyes, suggesting that flavoprotein fluorescence analysis could be a valuable tool for noninvasive detection of metabolic stress in this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of retinal metabolic stress resulting from central serous retinopathy. Field, MG., Elner, VM., Park, S., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11182218/

Flavoprotein fluorescence elevation is a marker of ... Recent studies of glaucoma, age-related macular degeneration, and diabetic retinopathy have demonstrated that flavoprotein fluorescence (FPF) can be utilized ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7852520/

Functional imaging of mitochondria in retinal diseases using ... For each CSCR patient, the affected eye showed greater retinal FPF than the fellow eye. CSCR eyes also averaged 98% higher FPF than controls.

3. iovs.arvojournals.org iovs.arvojournals.org/article.aspx?articleid=2810640

Flavoprotein Fluorescence Imaging in Stargardt Disease - IOVS Increased FPF signals were primarily associated with outer retinal damage. In some cases, increased FPF was observed in the absence of significant structural ...

4. eyewire.news eyewire.news/news/ocusciences-announces-publication-showing-potential-to-detect-retinal-diseases-with-high-sensitivity

OcuSciences Announces Publication Showing Potential to ... OcuSciences announced a publication in Frontiers in Ophthalmology that shows the potential to detect retinal diseases with high sensitivity.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06381596/retinal-fundus-flavoprotein-fluorescence-in-age-related-macular-degeneration?page=27&id=193&slug=aging

Retinal Fundus Flavoprotein Fluorescence in Age Related ... The study aims to evaluate patterns of anomalous fundus flavoprotein fluorescence (FPF) in patients with advanced geographic atrophy (GA) due to ...

6. frontiersin.org frontiersin.org/journals/ophthalmology/articles/10.3389/fopht.2023.1110501/full

Flavoprotein fluorescence elevation is a marker of ... Flavoprotein fluorescence (FPF) can be utilized non-invasively as an indicator of mitochondrial oxidative stress in the retina.

7. retinatoday.com retinatoday.com/articles/2022-nov-dec/retinal-imaging-pipeline-updates

Retinal Imaging Pipeline Updates The OcuMet Beacon can detect the presence of FPF at the optic nerve head, indicating mitochondrial dysfunction and glaucomatous damage.3 Ahsanuddin et al found ...

8. medicaldevice-network.com medicaldevice-network.com/news/ocusciences-gains-fda-clearance-on-retinal-health-scanner/

OcuSciences gains FDA clearance on retinal health scanner The US Food and Drug Administration (FDA) has cleared OcuSciences' retinal health assessment device, the OcuMet Beacon.