Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration

Last updated: April 16, 2025
Sponsor: University of Wisconsin, Madison
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aging

Geographic Atrophy

Myopic Macular Degeneration

Treatment

OcuMet Beacon

Clinical Study ID

NCT06381596
2023-1715
SMPH/OPHTHAL&VIS SCI/GEN
Protocol Version 3/6/2024
A536000
Protocol Version 11/26/2024
  • Ages > 50
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 50 years or older and may be either male or female of any race

  • Established diagnosis of GA due to AMD

  • GA characteristics: GA area of between 1.25 mm² and 23 mm², with seventy percent ofeyes having GA area ranging from 2.5 mm2 to 17.5 mm2. GA may be unifocal ormultifocal. GA may be subfoveal or extrafoveal, with twenty-five percent of eyeshaving subfoveal GA. The presence of concurrent peripapillary atrophy will notexclude subjects from participation

  • Willing to participate as evidenced by signing the written informed consent

Exclusion

Exclusion Criteria:

  • Unable to tolerate ophthalmic imaging

  • Presence of neovascular AMD on OCT as confirmed by an ophthalmologist

  • Presence of significant media opacity preventing adequate retinal imaging

  • Presence of concurrent retinal disease which may confound assessment

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: OcuMet Beacon
Phase:
Study Start date:
April 16, 2024
Estimated Completion Date:
August 31, 2025

Study Description

The goal of this clinical trial is to learn if areas of mitochondrial functional distress in the macula (as imaged using fundus flavoprotein fluorescence) correlate with areas of anatomic disease identified on standard fundus autofluorescence (FAF) imaging.

The study aims to evaluate patterns of anomalous fundus flavoprotein fluorescence (FPF) in patients with advanced geographic atrophy (GA) due to dry age-related macular degeneration.

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

Connect with a study center

  • Department of Ophthalmology and Visual Sciences

    Madison, Wisconsin 53705
    United States

    Active - Recruiting

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