Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration

Not Applicable

Recruiting

• Conditions: Geographic Atrophy; Age-Related Macular Degeneration
• Interventions: Device: OcuMet Beacon

• Registration Number: NCT06381596
• Lead Sponsor: University of Wisconsin, Madison

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-04-09
• Study Start: 2024-04-16
• Study First Submitted QC: 2024-04-19
• Study First Posted: 2024-04-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fundus autofluorescence (FAF) imaging	OcuMet Beacon	-

Primary Outcome Measures

Name	Time	Method
Limits of agreement between the fundus autofluorescence (FAF) area of GA images taken with the Heidelberg Spectralis to the flavoprotein fluorescence (FPF) area of GA with images taken with the OcuMet Beacon	Up to 45 minutes	The equivalence test will be performed using the estimated fixed effect coefficient and standard errors derived from the mixed-effects model, where the null hypothesis is that the difference in measurements between the two devices is outside the equivalence bounds of -2.5% to 2.5%.

Secondary Outcome Measures

Name	Time	Method
Compare the cross-sectional associations between FPF intensity (average pixel intensity over a 5.5 mm-diameter region centered at the macula) to FAF area at the time of measurement	Up to 45 minutes
Compare the cross-sectional associations between best corrected visual acuity (BCVA - using Early Treatment Diabetic Retinopathy Study, greater number of letters read correctly equals better vision) to FAF area at the time of measurement	Up to 45 minutes

Trial Locations

Locations (1)

Department of Ophthalmology and Visual Sciences; 🇺🇸 Madison, Wisconsin, United States