NCT05961332

Brief Summary

The goal of this clinical trial is to compare measurements of geographic atrophy (GA) area between several types of imaging, in order to assess accuracy. The main question to answer is which imaging device provides measurements that are most similar to the standard of care device. Participants will be patients of a retina doctor at University Station Eye Clinic with geographic atrophy, and can expect to be in the study for 60-75 minutes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 6, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2025

Completed
Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

1.6 years

First QC Date

July 18, 2023

Last Update Submit

June 6, 2025

Conditions

Macular Degeneration, Age RelatedGeographic Atrophy

Outcome Measures

Primary Outcomes (3)

  • Comparison of geographic atrophy area measurements by Clarus with standard Spectralis imaging

    Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the two devices.

    Up to 75 minutes

  • Comparison of geographic atrophy area measurements by Optos with standard Spectralis imaging

    Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the two devices.

    Up to 75 minutes

  • Comparison of geographic atrophy area measurements between Clarus and Optos

    Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the two devices.

    Up to 75 minutes

Secondary Outcomes (2)

  • Prevalence of atrophy outside the standard 30 degrees in Clarus and Optos ultrawide field images

    Up to 75 minutes

  • Prevalence of other autofluorescence abnormalities outside the standard 30 degrees in Clarus and Optos ultrawide field images

    Up to 75 minutes

Study Arms (1)

Fundus autofluorescence (FAF) imaging

EXPERIMENTAL
Device: Spectralis FAF imagingDevice: Optos imagingDevice: Zeiss Clarus 700 imaging

Interventions

Spectralis FAF imagingDEVICE

Spectralis is a scanning laser ophthalmoscope which uses a blue light excitation wavelength of 488nm and a 500nm barrier filter to produce FAF images. Spectralis images 20-55 degrees of the retina.

Fundus autofluorescence (FAF) imaging
Optos imagingDEVICE

Optos is an ultrawide field imaging platform which images up to 200 degrees of the retina. It uses both a green-light excitation wavelength of 532nm and a red-light excitation wavelength of 633nm with an emission filter of greater than 540nm to produce FAF images.

Fundus autofluorescence (FAF) imaging
Zeiss Clarus 700 imagingDEVICE

Zeiss Clarus 700 is an ultrawide field imaging system with similar retinal coverage to that of Optos. It uses Broad Line Fundus Imaging to produce blue FAF images at excitation wavelengths of 435-500nm and green FAF images at wavelengths of 500-585nm

Fundus autofluorescence (FAF) imaging

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older and may be either male or female and may be 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

You may not qualify if:

  • Unable to tolerate opthalmic 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Macular DegenerationGeographic Atrophy

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Amitha Domalpally, MD, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2023

First Posted

July 27, 2023

Study Start

October 6, 2023

Primary Completion

May 27, 2025

Study Completion

May 27, 2025

Last Updated

June 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)