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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 3/14/2025 | Other Identifier | UW Madison | |
| A536070 | Other Identifier | UW Madison |
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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.
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:
Eligible participants will undergo one retinal imaging session of both eyes for the following:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMD Benchmark Imaging Dataset Cohort | Study Procedures Include:
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retinal Imaging | Other | Eligible participants will undergo one retinal imaging session of both eyes for the following:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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. | up to 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wisconsin Reading Center | Contact | 1-608-262-1334 | wrc.support@wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amitha Domalpally, MD, PhD | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bergstrom Eye Research LLC | Recruiting | Fargo | North Dakota | 58103 | United States |
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| Erie Retina Research | Recruiting | Erie | Pennsylvania | 16507 | United States |
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| Retina Foundation of the Southwest | Recruiting | Dallas | Texas | 75231 | United States |
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| Valley Retina Institute | Recruiting | McAllen | Texas | 78503 | United States |
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| Retina Consultants of Texas (Houston) | Recruiting | The Woodlands | Texas | 77384 | United States |
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| University of Utah - John A. Moran Eye Center | Recruiting | Salt Lake City | Utah | 84132 | United States |
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| University Station Eye Care Clinic | Recruiting | Madison | Wisconsin | 53705 | United States |
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| Charles Research Center | Not yet recruiting | Buenos Aires | Argentina |
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| Adelaide Eye and Retina Centre | Not yet recruiting | Adelaide | 5000 | Australia |
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| Centre Hospialier Intercommunal de Paradis (Centre Monticelli Paradis) | Not yet recruiting | Marseille | 13008 | France |
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| University of Bonn - Department of Ophthalmology | Not yet recruiting | Bonn | 53127 | Germany |
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| Sankara Nethralaya, Medical Research Foundation | Recruiting | Chennai | Tamil Nadu | 600006 | India |
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| Aravind Eye Hospital | Recruiting | Chennai | Tamil Nadu | 641014 | India |
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| Aga Khan University | Recruiting | Karachi | 74800 | Pakistan |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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