Intelligent Evaluation of Diabetic Retinopathy (EVIRED)

January 13, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3183

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bobigny, France, 93000
        • CHU Avicenne
      • Bordeaux, France, 33000
        • CHU Bordeaux
      • Brest, France, 29200
        • CHU Brest
      • Créteil, France, 94010
        • CHIC Créteil
      • Dijon, France, 21000
        • CHU Dijon
      • Lyon, France, 69317
        • Chu Lyon Croix Rousse
      • Marseille, France, 13008
        • Clinique Monticelli
      • Nantes, France, 44000
        • Clinique ophtalmologique du CHU de Nantes
      • Nice, France, CS 51069_06001, Nice cedex1
        • CHU de NICE HÔPITAL PASTEUR 2
      • Paris, France, 75013
        • CHU Pitie Salpetriere
      • Paris, France, 75019
        • Fondation Rothschild
      • Paris, France, 75010
        • Chu Lariboisiere
      • Paris, France, 75013
        • Centre Broca / Mutuelle Generale
      • Paris, France, 75571
        • Hôpital des 15-20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

The study will concern patients with both type1 and type 2 diabetes mellitus, as well as other forms of more rare diabetes mellitus. As the goal of the study is to train the algorithms to predict the progression of DR at one year, we'll exclude diabetic patients with no risk of progression such as patients with type 1 diabetes and diabetes duration less than 10 years. This cohort of patients will include 10% of patients without DR of with minimal non proliferative DR, and 90% of patients with moderate non proliferative DR or more severe. All DR stages will be represented with, however, a greater proportion of patients with moderate or severe stages of DR which are at higher risk of DR progression.

If the recruitment rate is unsufficient to reach the anticipated sample size, no stratification of the recruitment will be imposed for the four last months of the study inclusion period.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression to severe retinopathy
Time Frame: month 12
Progression towards severe diabetic retinopathy form.
month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Algorithm performance
Time Frame: 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.
3 years
Comparison of algorithms prediction to human prediction.
Time Frame: 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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2020

Primary Completion (Actual)

December 18, 2025

Study Completion (Actual)

December 18, 2025

Study Registration Dates

First Submitted

September 7, 2020

First Submitted That Met QC Criteria

November 5, 2020

First Posted (Actual)

November 12, 2020

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP200697

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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