Clinical trial NCT06381596: Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration
Official title: Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration: New Insights From Multimodal Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Geographic Atrophy
Age-Related Macular Degeneration
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Up to 45 minutes
Secondary outcomes:
measure: 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
timeFrame: Up to 45 minutes
measure: 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
timeFrame: Up to 45 minutes
Other outcomes:
Locations:
city: Madison
country: United States
facility: Department of Ophthalmology and Visual Sciences
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Mihai Mititelu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: