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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06924021




Registration number
NCT06924021
Ethics application status
Date submitted
4/04/2025
Date registered
11/04/2025
Date last updated
22/07/2025

Titles & IDs
Public title
Age-Related Macular Degeneration Benchmark Imaging Dataset (ABID)
Scientific title
Age-Related Macular Degeneration Benchmark Imaging Dataset (ABID)
Secondary ID [1] 0 0
Protocol Version 3/14/2025
Secondary ID [2] 0 0
2025-0059
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-Related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Retinal Imaging

AMD Benchmark Imaging Dataset Cohort - Study Procedures Include:

* Patient history: demographics (age, sex, ethnicity, race), smoking history, family history of AMD
* Physical exam: height and weight
* Snellen best-corrected visual acuity (BCVA)
* AMD classification (Beckman scale)


Other interventions: Retinal Imaging
Eligible participants will undergo one retinal imaging session of both eyes for the following:

* Single field stereo color fundus photography (cFP) - pre and post dilation
* Macular spectral domain-optical coherence tomography (SD-OCT)
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
AMD Classification by Participant Count
Timepoint [1] 0 0
up to 18 months
Primary outcome [2] 0 0
Geographic Location by Participant Count
Timepoint [2] 0 0
up to 18 months

Eligibility
Key inclusion criteria
* Participants greater than or equal to 50 years of age at time of signing Informed Consent Form
* Willing to comply with all study procedures and sign the Informed Consent Form (ICF)
* Individuals with normal healthy eyes or diagnosed with any stage of Age-Related Macular Degeneration (treatment naïve patients with early, intermediate, or late AMD). The diagnosis and eligibility review will be confirmed by Central Reading Center.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Therapeutic treatment for any type of AMD, in either eye. Supplements, such as AREDS2 formula, are allowed.
* Unable to acquire adequate quality images, as evaluated by the Central Reading Center
* Severe vision loss requiring urgent surgery
* Contraindicated for acquiring retinal images due to narrow anterior chamber angles or hypersensitivity to light
* A systemic or ocular condition that in the opinion of the Investigator would preclude participation in the study
* Unwilling to sign informed consent form
* Currently or previously enrolled in an interventional AMD clinical trial

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/05/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2026
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Adelaide Eye and Retina Centre - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Dakota
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
United States of America
State/province [4] 0 0
Utah
Country [5] 0 0
United States of America
State/province [5] 0 0
Wisconsin
Country [6] 0 0
Argentina
State/province [6] 0 0
Buenos Aires
Country [7] 0 0
France
State/province [7] 0 0
Marseille
Country [8] 0 0
Germany
State/province [8] 0 0
Bonn
Country [9] 0 0
India
State/province [9] 0 0
Tamil Nadu
Country [10] 0 0
Pakistan
State/province [10] 0 0
Karachi

Funding & Sponsors
Primary sponsor type
Other
Name
University of Wisconsin, Madison
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amitha Domalpally, MD, PhD
Address 0 0
UW School of Medicine and Public Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Wisconsin Reading Center
Address 0 0
Country 0 0
Phone 0 0
1-608-262-1334
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06924021