Intelligent Evaluation of Diabetic Retinopathy

NCT04624737 | Completed

• 1 other identifier: APHP200697
• Study Type: interventional
• Target: 3,183
• Locations: 1 country
• Sites: 14

Brief Summary

Brief Summary: The main objective of EviRed project is to develop and validate a system assisting the ophthalmologist by improving prediction of evolution, and decision making during diabetic retinopathy (DR) follow-up for a patient. It will replace the current classification of diabetic retinopathy (DR) which provides an insufficient prediction precision. It will use modern available fundus imaging devices and artificial intelligence (AI) to properly integrate the amount of data they provide with other medical data of the patient. A cohort of 5000 diabetic patients will be recruited and followed for an average of 2 years in order to collect data to train and validate the new prediction system. An economic study will also be carried out.

Conditions

Diabetic Retinopathy

Keywords

Diabetic retinopathy. .; Diabetes; Artificial intelligence.; Deep learning

Outcome Measures

Primary Outcomes (1)

• Progression to severe retinopathy

  Progression towards severe diabetic retinopathy form.

  month 12

Secondary Outcomes (2)

• Algorithm performance

  3 years

• Comparison of algorithms prediction to human prediction.

  3 years

Interventions

Diagnostic DIAGNOSTIC_TEST

Des images et des vidéos de la rétine des deux yeux seront acquises en utilisant différentes modalités d'imagerie, notamment la photographie grand champ, l'OCT et l'angiographie OCT. Toutes les images et les données seront collectées grâce à une plateforme commune et centralisées sur un serveur.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient with type 1 or type 2 diabetes or other,
• aged 18 years or more,
• diabetes duration greater than 10 years for type 1 diabetes,
• patient affiliated to social security,
• women of childbearing potential who are unwilling or unable to use a method to avoid pregnancy; women who are pregnant or breastfeeding can be included in the study.

You may not qualify if:

• ungradable fundus photography or OCT/OCTA imaging in both eyes,
• previous treatment with vitrectomy in both eyes,
• participant is unable or unwilling to comply with study procedures (including foreign language speakers who are not assisted by a native language speaker),
• Gestational diabetes vulnerable participants (minors, legally detained),
• patients under legal protection (guardianship),
• prisoners or subjects who are involuntarily incarcerated,
• patients with untreated or treated proliferative DR and macular edema involving the center of the macula in both eyes or with panretinal photocoagulation and untreated or treated macular edema involving the center of the macula in both eyes.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (14)

Chu Avicenne

Bobigny, 93000, France

Location

Chu Bordeaux

Bordeaux, 33000, France

Location

Chu Brest

Brest, 29200, France

Location

Chic Creteil

Créteil, 94010, France

Location

Chu Dijon

Dijon, 21000, France

Location

Chu Lyon Croix Rousse

Lyon, 69317, France

Location

Clinique Monticelli

Marseille, 13008, France

Location

Clinique ophtalmologique du CHU de Nantes

Nantes, 44000, France

Location

CHU de NICE HÔPITAL PASTEUR 2

Nice, CS 51069_06001, Nice cedex1, France

Location

Chu Lariboisiere

Paris, 75010, France

Location

Centre Broca / Mutuelle Generale

Paris, 75013, France

Location

Chu Pitie Salpetriere

Paris, 75013, France

Location

Fondation Rothschild

Paris, 75019, France

Location

Hôpital des 15-20

Paris, 75571, France

Location

Related Publications (1)

• Tadayoni R, Massin P, Bonnin S, Magazzeni S, Lay B, Le Guilcher A, Vicaut E, Couturier A, Quellec G, Investigators E. Artificial intelligence-based prediction of diabetic retinopathy evolution (EviRed): protocol for a prospective cohort. BMJ Open. 2024 Apr 15;14(4):e084574. doi: 10.1136/bmjopen-2024-084574.

  PMID: 38626974 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Retinal images and videos of both eyes will be acquired using different imaging modalities including widefield photography, OCT and OCT angiography. All images and data will be collected thanks to a common platform and centralized on a server. The EVIRED cohort will be randomly split in two groups: one group of 4000 patients for building algorithms and one group of 1,000 patients to validate them (validation cohort)

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: November 12, 2020
• Study Start: December 21, 2020
• Primary Completion: December 18, 2025
• Study Completion: December 18, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

FR (14)