Age-Related Macular DegenerationNCT06924021
Age-Related Macular Degeneration Benchmark Imaging Dataset (ABID)
An observational study of Age-Related Macular Degeneration, run by University of Wisconsin, Madison at 15 sites in 7 countries.
Trial summary
1000 participants from up to 25 international locations who are at least 50 years old with either healthy eyes or a diagnosis of Age-Related Macular Degeneration (AMD) will be consented to provide images of their eyes for a new dataset. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Retinal Imaging
- How many people
- 1,000 participants
- Where
- 15 sitesin 7 countries
- Study dates
- 12 May 2025to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Approximately 1000 participants from up to 25 sites in the United States, Europe, Asia, South America, Africa, and Australia will be enrolled and balanced by age, sex, and AMD level (worse eye selected as study eye). Every region listed above may not be represented and additional regions/countries not listed above may be included.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
15 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 7 countries
United States8 sites, 8 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
Afif Martini, 404-778-5815, mohamed.afif.martini@emory.edu
Ayesha Hossain
- Recruiting
Retina Foundation of the Southwest
Dallas, Texas, 75231
214-363-3911
Karl Csaky
- Recruiting
Erie Retina Research
Erie, Pennsylvania, 16507
814-200-9152
David Almeida
- Recruiting
Bergstrom Eye Research LLC
Fargo, North Dakota, 58103
701-235-5200
Lance Bergstrom
- Recruiting
University Station Eye Care Clinic
Madison, Wisconsin, 53705
Site PI, 1-608-263-7171, wrc.support@wisc.edu
Amitha Domalpally
- Recruiting
Valley Retina Institute
McAllen, Texas, 78503
844-485-3202
Victor Gonzalez
- Recruiting
University of Utah - John A. Moran Eye Center
Salt Lake City, Utah, 84132
Steffen Schmitz-Valckenberg
- Recruiting
Retina Consultants of Texas (Houston)
The Woodlands, Texas, 77384
713-524-3434
Charles Wykoff
India2 sites, 2 recruiting
- Recruiting
Sankara Nethralaya, Medical Research Foundation
Chennai, Tamil Nadu, 600006
+91 44 2827 1616
Muna Bhende
- Recruiting
Aravind Eye Hospital
Chennai, Tamil Nadu, 641014
+91 44 4095 6100
Rodney Morris
Argentina1 site, 1 recruiting
- Not yet recruiting
Charles Research Center
Buenos Aires
Patricio Schlottmann
Australia1 site, 1 recruiting
- Recruiting
Adelaide Eye and Retina Centre
Adelaide, 5000
Kerin Haywood, +61 8 8212 3022, khaywood@adelaideeye.com.au
Jagjit Gilhotra
Germany1 site, 1 recruiting
- Not yet recruiting
University of Bonn - Department of Ophthalmology
Bonn, 53127
+49 228 28715505
Kristina Pfau
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University
Karachi, 74800
Haroon Tayyab
South Korea1 site, 1 recruiting
- Recruiting
Kim Eye Hospital
Seoul
GuHeui Jo, +82 1577-2639, fm@kimeye.com
Jae Hui Kim
About this study
1000 participants from up to 25 international locations who are at least 50 years old with either healthy eyes or a diagnosis of Age-Related Macular Degeneration (AMD) will be consented to provide images of their eyes for a new dataset. This dataset is an important step in developing an Artificial Intelligence (AI) based screening tool for AMD.
Read the detailed description
Age-related macular degeneration (AMD) is a leading cause of blindness in the world. The early and intermediate stages of AMD progress to late stage resulting in vision loss due to either geographic atrophy or neovascular AMD. Preventive measures to reduce treatment burden and prevent blindness are important. While there are no approved therapies for early disease, active research is underway. However, advancing therapeutic trials for AMD prevention remains challenging due to the lack of primary care involvement in early-stage AMD diagnosis.
A clear need exists for a reliable screening tool, deployable in optometry or primary care facilities to identify those with an early stage of disease. While an Artificial Intelligence (AI) based screening tool would be an ideal solution, there are obstacles to its prospective validation due to difficulty in enrolling sufficient cases in a screening environment. A key step towards promoting this field lies in collecting a diverse dataset of multimodal imaging and providing a reference standard level 1 classification from a wide array of patients with AMD. Having such a benchmark dataset available for research purposes will empower the development and validation of AI models for AMD. This data can serve as the much-sought pathway to the rapid development of screening models, facilitating the referral of patients with the appropriate disease spectrum, and ultimately leading to the prevention of late AMD.
This is a prospective, cross-sectional, multi-center, observational study to collect and develop a meticulously curated and diverse AMD benchmark dataset, featuring reference standard level 1 classification and comprehensive annotation of images.
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)
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)
Due to the need for diversity in the dataset, sites need to represent a wide array of geographical locations. In addition, balancing will be done on enrolled participants with or without AMD including age, sex, and AMD level (worse eye selected as study eye).
- Conditions
- Age-Related Macular Degeneration
- Being tested
- Retinal Imaging
- Keywords
- screening, artificial intelligence, AI
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinal ImagingOther
Also called Single field stereo color fundus photography, Macular spectral domain-optical coherence tomography
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Retinal Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMD Classification by Participant Count
A meticulously curated and diverse Benchmark dataset, featuring reference standard level 1 classification and annotated images for a wide range of AMD phenotypes is the primary outcome. Diversity of the dataset will in part be measured by classifying AMD status.
The goal is to have:
- 20% participants with no AMD
- 30% participants with Early AMD
- 30% participants with Intermediate AMD
- 10% participants with Geographic Atrophy (GA)
- 10% participants with Neovascular age-related macular degeneration (nAMD)
Measured: up to 18 months
Geographic Location by Participant Count
A meticulously curated and diverse Benchmark dataset, featuring reference standard level 1 classification and annotated images for a wide range of AMD phenotypes is the primary outcome. Diversity of the dataset will in part be measured by geographic location. 1000 participants from up to 25 global sites will be included.
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start12 May 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amitha Domalpally, MD, PhD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924021
- Sponsor's protocol ID
- 2025-0059
- Other IDs
- Protocol Version 3/14/2025, A536070
- Status last verified
- Mar 2026
- First submitted
- 4 Apr 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-Related Macular Degeneration Benchmark Imaging Dataset (ABID)
- ClinicalTrials.gov ID
- NCT06924021
- Acronym / sponsor ID
- 2025-0059
- Conditions
- Age-Related Macular Degeneration
- Keywords
- screening, artificial intelligence, AI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
1000 participants from up to 25 international locations who are at least 50 years old with either healthy eyes or a diagnosis of Age-Related Macular Degeneration (AMD) will be consented to provide images of their eyes for a new dataset. This dataset is an important step in developing an Artificial Intelligence (AI) based screening tool for AMD.
Detailed description
Age-related macular degeneration (AMD) is a leading cause of blindness in the world. The early and intermediate stages of AMD progress to late stage resulting in vision loss due to either geographic atrophy or neovascular AMD. Preventive measures to reduce treatment burden and prevent blindness are important. While there are no approved therapies for early disease, active research is underway. However, advancing therapeutic trials for AMD prevention remains challenging due to the lack of primary care involvement in early-stage AMD diagnosis.
A clear need exists for a reliable screening tool, deployable in optometry or primary care facilities to identify those with an early stage of disease. While an Artificial Intelligence (AI) based screening tool would be an ideal solution, there are obstacles to its prospective validation due to difficulty in enrolling sufficient cases in a screening environment. A key step towards promoting this field lies in collecting a diverse dataset of multimodal imaging and providing a reference standard level 1 classification from a wide array of patients with AMD. Having such a benchmark dataset available for research purposes will empower the development and validation of AI models for AMD. This data can serve as the much-sought pathway to the rapid development of screening models, facilitating the referral of patients with the appropriate disease spectrum, and ultimately leading to the prevention of late AMD.
This is a prospective, cross-sectional, multi-center, observational study to collect and develop a meticulously curated and diverse AMD benchmark dataset, featuring reference standard level 1 classification and comprehensive annotation of images.
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)
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)
Due to the need for diversity in the dataset, sites need to represent a wide array of geographical locations. In addition, balancing will be done on enrolled participants with or without AMD including age, sex, and AMD level (worse eye selected as study eye).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMD Benchmark Imaging Dataset Cohort | – | Other: Retinal ImagingStudy 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) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 1000 participants from up to 25 sites in the United States, Europe, Asia, South America, Africa, and Australia will be enrolled and balanced by age, sex, and AMD level (worse eye selected as study eye). Every region listed above may not be represented and additional regions/countries not listed above may be included.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retinal ImagingAlso: Single field stereo color fundus photography, Macular spectral domain-optical coherence tomographyEligible 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) | Other | AMD Benchmark Imaging Dataset Cohort |
Primary outcome
AMD Classification by Participant Count
Time frame: up to 18 months
A meticulously curated and diverse Benchmark dataset, featuring reference standard level 1 classification and annotated images for a wide range of AMD phenotypes is the primary outcome. Diversity of the dataset will in part be measured by classifying AMD status. The goal is to have: * 20% participants with no AMD * 30% participants with Early AMD * 30% participants with Intermediate AMD * 10% participants with Geographic Atrophy (GA) * 10% participants with Neovascular age-related macular degeneration (nAMD)
Geographic Location by Participant Count
Time frame: up to 18 months
A meticulously curated and diverse Benchmark dataset, featuring reference standard level 1 classification and annotated images for a wide range of AMD phenotypes is the primary outcome. Diversity of the dataset will in part be measured by geographic location. 1000 participants from up to 25 global sites will be included.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Age-Related Macular Degeneration
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amitha Domalpally, MD, PhD principal investigator
UW School of Medicine and Public Health
15 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related Macular Degeneration, run by University of Wisconsin, Madison at 15 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, India, Argentina, Australia, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wisconsin Reading Center (1-608-262-1334, wrc.support@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AMD Classification by Participant Count (time frame: up to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.