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NCT04624737Completed

Intelligent Evaluation of Diabetic Retinopathy

Source: ClinicalTrials.gov · Last updated 15 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
3183 (actual)
First submitted
7 Sept 2020
Start date
21 Dec 2020
Primary completion date
18 Dec 2025
Lead sponsor
Assistance Publique - Hôpitaux de Paris
NCT number
NCT04624737

What you commit to

  • Study type: Interventional
  • Participants enrolled: 3183
  • From 21 Dec 2020 to the primary completion date, 18 Dec 2025
  • 14 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • previous treatment with vitrectomy in both eyes,

Other illness

  • Gestational diabetes vulnerable participants (minors, legally detained),

Other

  • ungradable fundus photography or OCT/OCTA imaging 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),
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Avicenne
Coordinator of this site? Confirm its status
BobignyFranceUnknown status
CHU Bordeaux
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BordeauxFranceUnknown status
Chu Brest
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BrestFranceUnknown status
CHIC Créteil
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CréteilFranceUnknown status
CHU Dijon
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DijonFranceUnknown status
CHU Lyon, Croix-Rousse,
Coordinator of this site? Confirm its status
LyonFranceUnknown status
Clinique Monticelli
Coordinator of this site? Confirm its status
MarseilleFranceUnknown status
Clinique ophtalmologique du CHU de Nantes
Coordinator of this site? Confirm its status
NantesFranceUnknown status
CHU de Nice - Hôpital Pasteur 2
Coordinator of this site? Confirm its status
NiceFranceUnknown status
Centre Broca / Mutuelle Generale
Coordinator of this site? Confirm its status
ParisFranceUnknown status
CHU Pitie Salpetriere
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ParisFranceUnknown status
Fondation Rothschild
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ParisFranceUnknown status
Chu Lariboisiere
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ParisFranceUnknown status
Hôpital des 15-20
Coordinator of this site? Confirm its status
ParisFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.