Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-16

Study Completion Date

2025-05-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Geographic Atrophy Age-Related Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Fundus autofluorescence (FAF) imaging

Group Type EXPERIMENTAL

OcuMet Beacon

Intervention Type DEVICE

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

Interventions

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OcuMet Beacon

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No