Geographic AtrophyFPF in AMDNCT06381596
Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration
A study testing OcuMet Beacon in people with Geographic Atrophy and Age-Related Macular Degeneration, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Geographic Atrophy, Age-Related Macular Degeneration
- What is being tested?
- OcuMet Beacon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2024to 27 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Department of Ophthalmology and Visual Sciences
Madison, Wisconsin, 53705
About this study
Official title: Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration: New Insights From Multimodal Imaging
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.
Read the 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.
- Being tested
- OcuMet Beacon
- Medical subject headings
- Geographic Atrophy, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OcuMet BeaconDevice
OcuMet Beacon is a novel fundus camera the can detect, capture, and assess FPF.
| Study group | Role | What they receive |
|---|---|---|
| Fundus autofluorescence (FAF) imaging | Experimental | Not described Receives: Device: OcuMet Beacon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 45 minutes
Secondary outcomes (3)
Compare the Cross-sectional Associations Between FPF Intensity to FAF Area at the Time of Measurement
FPF 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).
Measured: 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
Measured: Up to 45 minutes
Correlation Between FPF-intensity, FPF-heterogeneity and Participant 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 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.
Measured: up to 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start16 Apr 2024
- Primary completion27 May 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Geographic AtrophyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mihai Mititelu, MD, MPH, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381596
- Sponsor's protocol ID
- 2023-1715
- Other IDs
- A536000, SMPH/OPHTHAL&VIS SCI/GEN, Protocol Version 11/6/2024
- Acronym
- FPF in AMD
- Status last verified
- Jul 2026
- First submitted
- 9 Apr 2024
- Last updated
- 29 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration: New Insights From Multimodal Imaging
- ClinicalTrials.gov ID
- NCT06381596
- Acronym / sponsor ID
- FPF in AMD / 2023-1715
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Posted 29 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fundus autofluorescence (FAF) imaging | Experimental | Device: OcuMet Beacon |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OcuMet BeaconOcuMet Beacon is a novel fundus camera the can detect, capture, and assess FPF. | Device | Fundus autofluorescence (FAF) imaging |
Primary outcome
Optical Coherence Tomography (OCT) Variables
Time frame: up to 45 minutes
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.
Flavoprotein Fluorescence (FPF) Intensity
Time frame: Up to 45 minutes
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.
FPF Heterogeneity
Time frame: up to 45 minutes
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.
Correlation Between FPF-intensity, FPF-heterogeneity and OCT Continuous Variables
Time frame: up to 45 minutes
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.
3 secondary outcomes
Compare the Cross-sectional Associations Between FPF Intensity to FAF Area at the Time of Measurement
Time frame: 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
Time frame: Up to 45 minutes
Correlation Between FPF-intensity, FPF-heterogeneity and Participant Variables
Time frame: up to 45 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Geographic Atrophy
Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 3
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
Age-related Macular Degeneration (AMD), Geographic Atrophy (GA)
RecruitingPhase 1
Phase 1 Study of C.001 in Retinal Degeneration
Geographic Atrophy, Stargardt Disease
RecruitingPhase 2/3
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Geographic Atrophy, Macular Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mihai Mititelu, MD, MPH principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OcuMet Beacon in people with Geographic Atrophy and Age-Related Macular Degeneration, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optical Coherence Tomography (OCT) Variables (time frame: up to 45 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.