Trial Outcomes & Findings for Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration (NCT NCT06381596)
NCT ID: NCT06381596
Last Updated: 2026-07-29
Results Overview
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.
COMPLETED
NA
32 participants
up to 45 minutes
2026-07-29
Participant Flow
Participants who were enrolled in 2023-0958 (NCT05961332) and met the inclusion criteria were recruited to this study from April 2024 to May 2025.
Unit of analysis: eyes
Participant milestones
| Measure |
Fundus Autofluorescence (FAF) Imaging
OcuMet Beacon: OcuMet Beacon is a novel fundus camera the can detect, capture, and assess FPF.
|
|---|---|
|
Overall Study
STARTED
|
32 55
|
|
Overall Study
Analysis Population
|
26 41
|
|
Overall Study
COMPLETED
|
26 41
|
|
Overall Study
NOT COMPLETED
|
6 14
|
Reasons for withdrawal
| Measure |
Fundus Autofluorescence (FAF) Imaging
OcuMet Beacon: OcuMet Beacon is a novel fundus camera the can detect, capture, and assess FPF.
|
|---|---|
|
Overall Study
Had eyes that were screened out for image quality and excluded for neovascularization
|
6
|
Baseline Characteristics
Data reported for the analysis population only.
Baseline characteristics by cohort
| Measure |
Fundus Autofluorescence (FAF) Imaging
n=55 eyes
OcuMet Beacon: OcuMet Beacon is a novel fundus camera the can detect, capture, and assess FPF.
|
|---|---|
|
Age, Continuous
|
78.308 years
STANDARD_DEVIATION 7.047 • n=26 Participants • Data reported for the analysis population only.
|
|
Sex: Female, Male
Female
|
21 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=32 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=32 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=32 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=32 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=32 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=32 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=32 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=32 Participants
|
|
Laterality
Single Eye
|
11 Participants
n=26 Participants • Data for the N=26 participants included in the final analysis.
|
|
Laterality
Both Eyes
|
15 Participants
n=26 Participants • Data for the N=26 participants included in the final analysis.
|
|
Lens Status
Pseudophakic
|
23 eyes
n=41 eyes • Data reported for 26 participants and 41 eyes that were part of the analysis population.
|
|
Lens Status
Phakic
|
18 eyes
n=41 eyes • Data reported for 26 participants and 41 eyes that were part of the analysis population.
|
|
Best Corrected Visual Acuity (BCVA)
|
0.456 logMAR
STANDARD_DEVIATION 0.314 • n=40 eyes • Data reported for the analysis population only.
|
PRIMARY outcome
Timeframe: up to 45 minutesEllipsoid 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.
Outcome measures
| Measure |
FPF-Heterogeneity: OcuMet Beacon
A measure of variability in retinal mitochondrial flavoprotein fluorescence (FPF) across the macula, measured with the OcuMet Beacon.
|
Fundus Autofluorescence (FAF) Imaging: Heidelberg Spectralis
n=41 eyes
The data including FAF/ GA area and OCT measures are from Heidelberg Spectralis
|
|---|---|---|
|
Optical Coherence Tomography (OCT) Variables
EZ loss
|
—
|
9.911 millimeters squared
Standard Deviation 6.937
|
|
Optical Coherence Tomography (OCT) Variables
RPE Loss
|
—
|
7.362 millimeters squared
Standard Deviation 5.534
|
|
Optical Coherence Tomography (OCT) Variables
GA
|
—
|
7.635 millimeters squared
Standard Deviation 6.548
|
PRIMARY outcome
Timeframe: Up to 45 minutesAverage 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.
Outcome measures
| Measure |
FPF-Heterogeneity: OcuMet Beacon
A measure of variability in retinal mitochondrial flavoprotein fluorescence (FPF) across the macula, measured with the OcuMet Beacon.
|
Fundus Autofluorescence (FAF) Imaging: Heidelberg Spectralis
n=41 eyes
The data including FAF/ GA area and OCT measures are from Heidelberg Spectralis
|
|---|---|---|
|
Flavoprotein Fluorescence (FPF) Intensity
|
—
|
56.168 score on a scale
Standard Deviation 28.543
|
PRIMARY outcome
Timeframe: up to 45 minutesThis 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.
Outcome measures
| Measure |
FPF-Heterogeneity: OcuMet Beacon
A measure of variability in retinal mitochondrial flavoprotein fluorescence (FPF) across the macula, measured with the OcuMet Beacon.
|
Fundus Autofluorescence (FAF) Imaging: Heidelberg Spectralis
n=41 eyes
The data including FAF/ GA area and OCT measures are from Heidelberg Spectralis
|
|---|---|---|
|
FPF Heterogeneity
|
—
|
1.087 arbitrary units
Standard Deviation 0.136
|
PRIMARY outcome
Timeframe: up to 45 minutesSpearman'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.
Outcome measures
| Measure |
FPF-Heterogeneity: OcuMet Beacon
n=41 eyes
A measure of variability in retinal mitochondrial flavoprotein fluorescence (FPF) across the macula, measured with the OcuMet Beacon.
|
Fundus Autofluorescence (FAF) Imaging: Heidelberg Spectralis
n=41 eyes
The data including FAF/ GA area and OCT measures are from Heidelberg Spectralis
|
|---|---|---|
|
Correlation Between FPF-intensity, FPF-heterogeneity and OCT Continuous Variables
EZ Loss: Full [Heidelberg Spectralis]
|
0.445 correlation coefficient
Interval 0.082 to 0.693
|
0.441 correlation coefficient
Interval 0.073 to 0.693
|
|
Correlation Between FPF-intensity, FPF-heterogeneity and OCT Continuous Variables
RPE Loss: Full [Heidelberg Spectralis]
|
0.432 correlation coefficient
Interval 0.085 to 0.682
|
0.406 correlation coefficient
Interval 0.041 to 0.661
|
|
Correlation Between FPF-intensity, FPF-heterogeneity and OCT Continuous Variables
GA: Full [Heidelberg Spectralis]
|
0.445 correlation coefficient
Interval 0.095 to 0.681
|
0.414 correlation coefficient
Interval 0.046 to 0.667
|
SECONDARY outcome
Timeframe: Up to 45 minutesFPF Intensity is the average pixel intensity over a 5.5 mm-diameter region centered at the macula (measured in gray scale units) compared to are of Geographic Atrophy (measured in millimeters squared). 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).
Outcome measures
| Measure |
FPF-Heterogeneity: OcuMet Beacon
A measure of variability in retinal mitochondrial flavoprotein fluorescence (FPF) across the macula, measured with the OcuMet Beacon.
|
Fundus Autofluorescence (FAF) Imaging: Heidelberg Spectralis
n=41 eyes
The data including FAF/ GA area and OCT measures are from Heidelberg Spectralis
|
|---|---|---|
|
Compare the Cross-sectional Associations Between FPF Intensity to FAF Area at the Time of Measurement
|
—
|
0.414 correlation coefficient
Interval 0.046 to 0.667
|
SECONDARY outcome
Timeframe: Up to 45 minutesOutcome measures
| Measure |
FPF-Heterogeneity: OcuMet Beacon
A measure of variability in retinal mitochondrial flavoprotein fluorescence (FPF) across the macula, measured with the OcuMet Beacon.
|
Fundus Autofluorescence (FAF) Imaging: Heidelberg Spectralis
n=40 eyes
The data including FAF/ GA area and OCT measures are from Heidelberg Spectralis
|
|---|---|---|
|
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
|
—
|
0.35 correlation coefficient
Interval -0.015 to 0.642
|
SECONDARY outcome
Timeframe: up to 45 minutesPopulation: There is one eye missing the Snellen fraction.
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 continuous demographic and FAF/OCT variables (i.e. age and logMAR values). To account for correlation between eyes belonging to the same patient, p-values were obtained via nonparametric bootstrap resampling at the patient level. Participant variables are reported in the baseline characteristics section.
Outcome measures
| Measure |
FPF-Heterogeneity: OcuMet Beacon
n=41 eyes
A measure of variability in retinal mitochondrial flavoprotein fluorescence (FPF) across the macula, measured with the OcuMet Beacon.
|
Fundus Autofluorescence (FAF) Imaging: Heidelberg Spectralis
n=41 eyes
The data including FAF/ GA area and OCT measures are from Heidelberg Spectralis
|
|---|---|---|
|
Correlation Between FPF-intensity, FPF-heterogeneity and Participant Variables
LogMAR
|
0 correlation coefficient
Interval -0.352 to 0.296
|
0.374 correlation coefficient
Interval 0.044 to 0.608
|
|
Correlation Between FPF-intensity, FPF-heterogeneity and Participant Variables
Age
|
0.074 correlation coefficient
Interval -0.313 to 0.444
|
-0.111 correlation coefficient
Interval -0.473 to 0.297
|
Adverse Events
Fundus Autofluorescence (FAF) Imaging
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place