Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration (FPF in AMD)

University of Wisconsin (UW)

Status: Completed

Conditions: Age-Related Macular Degeneration; Geographic Atrophy

Treatments: Device: OcuMet Beacon

Study type: Interventional

Funder types: Other

Identifiers

NCT06381596

Protocol Version 11/26/2024 (Other Identifier)

2023-1715

SMPH/OPHTHAL&VIS SCI/GEN (Other Identifier)

A536000 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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 of eyes having GA area ranging from 2.5 mm2 to 17.5 mm2. GA may be unifocal or multifocal. GA may be subfoveal or extrafoveal, with twenty-five percent of eyes having subfoveal GA. The presence of concurrent peripapillary atrophy will not exclude subjects from participation
• Willing to participate as evidenced by signing the written informed consent

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Fundus autofluorescence (FAF) imaging

Experimental group

Treatment:

Device: OcuMet Beacon