Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration

NCT06381596 | Completed DMC FDA Device

• 4 other identifiers: 2023-1715A536000SMPH/OPHTHAL&VIS SCI/GENProtocol Version 11/26/2024
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Geographic Atrophy; Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• 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

  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%.

  Up to 45 minutes

Secondary Outcomes (2)

• 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

Study Arms (1)

Fundus autofluorescence (FAF) imaging

EXPERIMENTAL

Device: OcuMet Beacon

Interventions

OcuMet Beacon DEVICE

OcuMet Beacon is a novel fundus camera the can detect, capture, and assess FPF.

Fundus autofluorescence (FAF) imaging

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

Department of Ophthalmology and Visual Sciences

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Geographic Atrophy; Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Mihai Mititelu, MD, MPH

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 24, 2024
• Study Start: April 16, 2024
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)