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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if the areas of stressed cells in the retina correlate to areas of disease identified in standard imaging and whether the images are helpful to identify potential areas of concern before symptoms or disease occurs. The main question it aims to answer is: * to evaluate patterns of increased autofluorescence FPF in the setting of geographic atrophy Participants will undergo FPF imaging using the OcuMet Beacon system.

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 data supports the effectiveness of the treatment FPF Imaging, Flavoprotein Fluorescence Imaging, OcuMet Beacon System for age-related macular degeneration?

Research shows that increased flavoprotein fluorescence (FPF) can indicate mitochondrial dysfunction, which is linked to age-related macular degeneration (AMD). This suggests that FPF imaging might help detect changes in the eye related to AMD. ^{1 2 3 4 5}

How is the OcuMet Beacon treatment different from other treatments for age-related macular degeneration?

The OcuMet Beacon treatment uses Flavoprotein Fluorescence Imaging, which is a unique method that detects changes in cellular metabolism in the eye, potentially identifying early alterations in age-related macular degeneration before they become visible with other imaging techniques. ^{2 6 7 8 9}

Research Team

Mihai Mititelu, MD, MPH

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

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

Detection of retinal metabolic stress resulting from central serous retinopathy. [2021]

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

CORRELATION STUDY BETWEEN DRUSEN MORPHOLOGY AND FUNDUS AUTOFLUORESCENCE. [2021]

3. England pubmed.ncbi.nlm.nih.gov

A new method of image analysis of fluorescein angiography applied to age-related macular degeneration. [2009]

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

Noninvasive imaging of mitochondrial dysfunction in dry age-related macular degeneration. [2012]

5. Germany 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. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

[Comparison of parameters of time-resolved autofluorescence between healthy subjects and patients suffering from early AMD]. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Green emission fluorophores in eyes with atrophic age-related macular degeneration: a colour fundus autofluorescence pilot study. [2019]

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

ABUNDANCE AND MULTIMODAL VISIBILITY OF SOFT DRUSEN IN EARLY AGE-RELATED MACULAR DEGENERATION: A Clinicopathologic Correlation. [2023]

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

Development and Optimization of a Fluorescent Imaging System to Detect Amyloid-β Proteins: Phantom Study. [2020]