OcuMet Beacon for Age-Related Macular Degeneration

(FPF in AMD Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Mihai Mititelu, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Wisconsin, Madison

Disqualifiers: Neovascular AMD, Media opacity, others

No Placebo Group

Approved in 2 Jurisdictions

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.

Trial 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 (Procedure)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Department of Ophthalmology and Visual Sciences Madison, WI

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1249

Patients Recruited

3,255,000+

Findings from Research

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

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]

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]

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]

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]