Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration

Age-Related Macular Degeneration Clinical Trial

— FPF in AMD  

Official title:

Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration: New Insights From Multimodal Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06381596
• Other study ID #: 2023-1715
• Secondary ID: A536000SMPH/OPHT
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2024
• Est. completion date: April 2025

Study information

• Verified date: May 2024
• Source: University of Wisconsin, Madison
• Contact: Amy Remm
• Phone: 608-262-3377
• Email: amy.remm[@]wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Geographic Atrophy
• Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
United States	Department of Ophthalmology and Visual Sciences	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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