Intelligent Evaluation of Diabetic Retinopathy

Active, not recruiting

• Conditions: Diabetic Retinopathy

• Registration Number: NCT04624737
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

A cohort of 5,000 diabetic patients with different stages of DR will be recruited and followed for an average of 2 years. Each year, general data as well as ophthalmological data will be collected. Retinal images and videos of both eyes will be acquired using different imaging modalities including ultrawidefield photography, OCT and OCT angiography. The EviRed cohort will be split in two groups: one group of 1,000 patients (validation cohort) will be randomly selected during the inclusion period by unbalanced draw to be representative of the general diabetic population. Their data will be used for the validation of the algorithms. The data of the remaining 4,000 patients (training cohort) will be used to train the algorithms. The main objective will be the validation of the prognostic tool and evaluate how accurately the algorithm can predict progression to severe retinopathy in the following year. Secondary objectives will be to evaluate how accurately the algorithm can assess DR severity and individual components of severe DR, predict progression to severe retinopathy, visual decrease, occurrence of fluid in the macula area in an eye, DR progression in an eye and for a patient, as well as to compare prediction by algorithm with the one made by ophthalmologists based on the current DR classification and their clinical experience. Secondary outcome measures will be sensitivity, specificity and AUC of the algorithm for detecting DR severity and individual components of severe DR, prediction of DR progression towards a severe form of DR, visual decrease, occurrence of fluid in the macular area in an eye, as well as to predict DR progression in an eye and for a patient.

Economic study Healthcare reimbursement data will also be collected and analyzed from Health Insurance. The inclusion and follow-up period of the cohort runs from 12/21/2020 to 12/21/2024, with follow-up durations varying from 1 to 3 years.

Study Timeline

• Study First Submitted: 2020-09-07
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-12
• Study Start: 2020-12-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10
• Primary Completion: 2024-12-21
• Study Completion: 2025-02-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression to severe retinopathy	month 12	Progression towards severe diabetic retinopathy form.

Secondary Outcome Measures

Name	Time	Method
Algorithm performance	3 years	Algorithms will be evaluated by comparing the algorithm performance to automatically assess diabetic retinopathy severity as well as individual components of severe retinopathy against the same grading made by human graders.
Comparison of algorithms prediction to human prediction.	3 years	at each patient's visit of the validation cohort, ophthalmologists will evaluate the risk of DR progression based on the current DR classification and their clinical experience. The risk of DR will be expressed by the clinician as a continuous variable (its estimated probability of progression) or as a semi-quantitative variable. Performance of the human prediction will be compared to the algorithm using sensitivity, specificity and AUC.

Trial Locations

Locations (14)

Chu Avicenne; 🇫🇷 Bobigny, France

Chu Bordeaux; 🇫🇷 Bordeaux, France

Chu Brest; 🇫🇷 Brest, France

Chic Creteil; 🇫🇷 Créteil, France

Chu Dijon; 🇫🇷 Dijon, France

Chu Lyon Croix Rousse; 🇫🇷 Lyon, France

Clinique Monticelli; 🇫🇷 Marseille, France

Clinique ophtalmologique du CHU de Nantes; 🇫🇷 Nantes, France

CHU de NICE HÔPITAL PASTEUR 2; 🇫🇷 Nice, France

Chu Lariboisiere; 🇫🇷 Paris, France

Centre Broca / Mutuelle Generale; 🇫🇷 Paris, France

Chu Pitie Salpetriere; 🇫🇷 Paris, France

Fondation Rothschild; 🇫🇷 Paris, France

Hôpital des 15-20; 🇫🇷 Paris, France