Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration

NCT06381596 | Completed Results DMC FDA Device

• 4 other identifiers: 2023-1715A536000SMPH/OPHTHAL&VIS SCI/GENProtocol Version 11/6/2024
• Study Type: interventional
• Target: 32
• 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 (4)

• Optical Coherence Tomography (OCT) Variables

  Ellipsoid Zone (EZ) loss refers to damaged photoreceptors in the eye. Retinal Pigment Epithelium (RPE) are cells that nourish photoreceptors in the eye, RPE loss is a measure of the degradation of these cells. Geographic Atrophy (GA) is an advanced stage of macular degeneration. These OCT variables are measured in millimeters squared from images taken with the Heidelberg Spectralis.

  up to 45 minutes

• Flavoprotein Fluorescence (FPF) Intensity

  Average pixel intensity over a 5.5 mm-diameter region centered at the macula, a measure of oxidative stress. Data range from 0-100 where higher numbers indicate more severe disease. This is measured with the OcuMet Beacon.

  Up to 45 minutes

• FPF Heterogeneity

  This is a measure of variability in retinal mitochondrial flavoprotein fluorescence (FPF) across the macula. It is a parameter that measures distribution and spatial variability of fluorescent signal by quantifying signal distribution of energy in localized hotspots, normalized to background. Normal values are less than 1 AU (arbitrary units), with values higher than 1 AU (in the range of 1-10 AU) corresponding to increased levels of metabolic distress due to oxidized mitocondria within the particular area of the retina that was imaged. This is measured with the OcuMet Beacon.

  up to 45 minutes

• Correlation Between FPF-intensity, FPF-heterogeneity and OCT Continuous Variables

  Spearman's rank coefficient was chosen as the primary metric due to the relatively small number of eyes in our sample as well as the lack of normally-distributed data (confirmed by Shapiro-Wilk tests, evaluated at α=0.05). Correlations were calculated between both FPF biomarkers and all FAF/OCT variables (i.e. areas of GA, EZ loss, and RPE loss). To account for correlation between eyes belonging to the same patient, p-values were obtained via nonparametric bootstrap resampling at the patient level.

  up to 45 minutes

Secondary Outcomes (3)

• Compare the Cross-sectional Associations Between FPF Intensity 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

• Correlation Between FPF-intensity, FPF-heterogeneity and Participant Variables

  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

Results Point of Contact

• Title: Britney Naolhu
• Organization: University of Wisconsin - Madison

bnaolhu@wisc.edu

(224) 567-9491

Study Officials

• Mihai Mititelu, MD, MPH

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: July 29, 2026
• Results First Posted: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)