Using AI to predict diabetic neurodegenerative disorders through retinal imaging

Predicting the Risk of Diabetic Neurodegenerative Disorders by Artificial Intelligence Tools Based on Retinal Imaging-DINEURET (PNRR-MCNT2-2023-12378367)

This study is testing whether artificial intelligence can help predict brain problems in people with type 2 diabetes by looking at their eye images.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: Ospedale San Raffaele (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Milan)
• Trial ID: NCT06541834 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the risk of diabetic neurodegenerative disorders by utilizing artificial intelligence tools that analyze retinal imaging. It focuses on patients with type 2 diabetes and examines the relationship between retinal vascular abnormalities and cognitive impairment. By employing deep-learning convolutional neural networks, the study seeks to identify clinical metrics and systemic conditions that may not be visible to human observers. The goal is to establish a non-invasive method for predicting complications associated with diabetes.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals over 45 years old diagnosed with type 2 diabetes who have not received treatment for diabetic retinopathy.

Not a fit: Patients with other retinal diseases, diabetic macular edema, or proliferative diabetic retinopathy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to earlier detection and intervention for patients at risk of cognitive impairment due to diabetes.

How similar studies have performed: Other studies have shown promise in using AI for retinal imaging, indicating potential success for this novel approach.

Eligibility criteria

Inclusion Criteria:

1. Male or female \> 45 years-old;
2. Diagnosis of type 2 DM;
3. No previous treatment for diabetic retinopathy;
4. Clear ocular media;
5. Ability to communicate well with the Investigator and to understand and comply with the requirements of the study;
6. Ability to provide written informed consent in accordance with institutional, local and national regulatory guidelines and to attend all study visits

Exclusion Criteria:

1. Patients affected by other retinal disease than diabetic retinopathy;
2. Presence of diabetic macular edema;
3. Presence of proliferative diabetic retinopathy;
4. Any media opacities, including corneal opacity, cataract formation and hemorrhage in the vitreous body, which may interfere with viewing by the laser surgeon of the target structures in the study eye(s). Subject requiring cataract surgery in the next 12 months must be excluded;
5. Aphakic eye(s) with vitreous in the anterior chamber;
6. Neovascular glaucoma;
7. Glaucoma caused by congenital angle anomalies;
8. Open angle of less than 90º or extensive peripheral anterior and low synechia, present circumferentially around the corner;
9. Glaucoma secondary to active uveitis;
10. Any other ocular condition that would progress in the study period and confound visual acuity assessment a part from diabetic retinopathy;
11. Presence of idiopathic or autoimmune-associated uveitis;
12. Any ocular or systemic medication known to be toxic to the lens, retina or optic nerve;
13. Any intra-ocular surgery on a qualifying eye within three months prior to entry in the study;
14. Any prior thermal laser in the macula or intravitreal injections or panphotocoagulation;
15. History of vitrectomy, filtering surgery, corneal transplant or retinal detachment surgery;
16. Previous therapeutic radiation in the ocular region in either eye;
17. Participation in an investigational drug, biologic, or device study within 6 months prior to baseline \[Note: observational clinical studies solely involving over-the-counter vitamins, supplements, or diets are not exclusionary\];
18. Has a serious medical illness that will prevent the subject from performing study activities (including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease) or, in the judgement of the Investigator, is likely to require surgical intervention or hospitalization at any point during the study;
19. In the opinion of the Investigator, is unlikely to comply with the study protocol.

Where this trial is running

Milan

• Ospedale San Raffaele — Milan, Italy (Recruiting)

Study contacts

• Study coordinator: Giuseppe Querques, MD, PhD

Conditions Diabete Mellitus; Cognitive Impairment