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Diabetic RetinopathyEVIREDNCT04624737

Intelligent Evaluation of Diabetic Retinopathy

A study testing Diagnostic in people with Diabetic Retinopathy, run by Assistance Publique - Hôpitaux de Paris at 14 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Retinopathy
What is being tested?
Diagnostic
How many people
3,183 participants
Where
14 sitesFrance
Study dates
21 Dec 2020to 18 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

France14 sites

  • Chu Avicenne

    Bobigny, 93000

  • Chu Bordeaux

    Bordeaux, 33000

  • Chu Brest

    Brest, 29200

  • Chic Creteil

    Créteil, 94010

  • Chu Dijon

    Dijon, 21000

  • Chu Lyon Croix Rousse

    Lyon, 69317

  • Clinique Monticelli

    Marseille, 13008

  • Clinique ophtalmologique du CHU de Nantes

    Nantes, 44000

  • CHU de NICE HÔPITAL PASTEUR 2

    Nice, CS 51069_06001, Nice cedex1

  • Chu Lariboisiere

    Paris, 75010

  • Centre Broca / Mutuelle Generale

    Paris, 75013

  • Chu Pitie Salpetriere

    Paris, 75013

  • Fondation Rothschild

    Paris, 75019

  • Hôpital des 15-20

    Paris, 75571

Other trials in France

About this study

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.

Read the 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.

Being tested
Diagnostic
Keywords
Diabetic retinopathy. ., Diabetes, Artificial intelligence., Deep learning
Medical subject headings
Diabetic Retinopathy, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DiagnosticDiagnostic 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression to severe retinopathy

    Progression towards severe diabetic retinopathy form.

    Measured: month 12

Secondary outcomes (2)

  1. Algorithm performance

    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.

    Measured: 3 years

  2. Comparison of algorithms prediction to human prediction.

    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.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2020
  2. Study start21 Dec 2020
  3. Primary completion18 Dec 2025
  4. Study completion18 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Model description
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)
Masking
None (open label)
Enrolment
3,183 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04624737
Sponsor's protocol ID
APHP200697
Acronym
EVIRED
Status last verified
Jan 2026
First submitted
7 Sep 2020
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38626974

Questions about this trial

What is this clinical trial studying?

A study testing Diagnostic in people with Diabetic Retinopathy, run by Assistance Publique - Hôpitaux de Paris at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression to severe retinopathy (time frame: month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04624737, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.

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