Using AI to screen for diabetic retinopathy
Official title: Assessing of Artificial Intelligence-based Software Platform for Diabetic Retinopathy Screening
Run by The Filatov Institute of Eye Diseases and Tissue Therapy · NCT06879834 · Data updated 2026-11-12
This study tests if an AI program can accurately find signs of diabetic retinopathy in eye images taken from people with diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | The Filatov Institute of Eye Diseases and Tissue Therapy Academic / other |
| Locations | 1 site (Odesa) |
| Status | Recruiting |
| Started | November 2, 2024 |
| Main results expected | August 2025 |
| Study ends | December 2025 |
| Registry record updated | March 17, 2025 |
| Trial ID | NCT06879834 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with a documented diagnosis of diabetes mellitus.
✕Probably not a fit
Patients under 18, those unable to provide informed consent, or individuals with other retinal diseases will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study examines the effectiveness of an artificial intelligence-based software platform, Retina-AI, in detecting diabetic retinopathy (DR). Participants will have fundus images taken with a non-mydriatic camera, following a specific imaging protocol. These images will then be uploaded to the AI system for analysis by a neural network to assess the presence of DR. The goal is to evaluate the accuracy and reliability of this AI tool in a clinical setting.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate detection of diabetic retinopathy, improving patient outcomes.
How similar studies have gone: Other studies have shown promise in using AI for medical imaging, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Documented diagnosis of diabetes mellitus by definition. 2. Understanding of the Study and willingness and ability to sign informed consent 3. Patient age 18 or above 4. Diagnostic for diabetes: 4a) Type 1 diabetes of a lest 5 years of evolution; or 4b) Type 2 diabetes Exclusion Criteria: -1. Patients under 18 years of age; 2. Failure to give informed consent; 3. Presence of retinal diseases - acquired disease: age-related macular degeneration (AMD), occlusion of retinal vessels (ORV), etc.; birth defects: coloboma of choroid or optic nerve disc, etc.; hereditary diseases: retinitis pigmentosa, angioid streaks of the retina, etc. 4\. A patient who has already undergone treatment (surgery, laser, etc.) for any disease of the retina: age-related macular degeneration (AMD), retinal vascular occlusion (ARV), etc. These patients should be excluded or allocated to a separate group.
Where it's running
-
The Filatov Institute of Eye Diseases and Tissue Therapy
Odesa, Ukraine Recruiting
Study contacts
- Principal investigator: Andrii MD Korol, PhD — The Filatov Institute of Eye Diseases and Tissue Therapy
- Study coordinator: Andrii MD Korol, PhD
- Email: andrii.r.korol@gmail.com
- Phone: 380936327266
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Corticosteroid for Diabetic Macular Edema (DME) in Adults with Diabetic Retinopathy
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Automated detection of diabetic retinopathy lesions in fundus photos
This study tests a smart imaging system within the DDART device to see if it can reliably spot diabetic retinopathy lesions in color fundus photographs.
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This observational study tests how retinal blood vessel patterns seen on OCTA relate to vision and blood sugar control in adults with diabetic retinopathy.
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MK-8748 vs. aflibercept for diabetic macular edema
This trial tests whether the investigational medicine MK-8748 can treat diabetic macular edema as well as the standard treatment aflibercept in adults with diabetes.
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MK-8748 vs aflibercept for diabetic macular edema
This trial tests whether MK-8748 can treat diabetic macular edema as well as the standard treatment aflibercept in people with diabetes.
-
Surabgene Lomparvovec in the Suprachoroidal Space for Diabetic Retinopathy
This study tests a one-time gene therapy called surabgene lomparvovec to see if it can help adults with non-proliferative diabetic retinopathy avoid vision-threatening events.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.