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
- Diseases
- Diabetic eye disease
- 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
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Avicenne Coordinator of this site? Confirm its status | Bobigny | France | Unknown status |
| CHU Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Chu Brest Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| CHIC Créteil Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| CHU Dijon Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| CHU Lyon, Croix-Rousse, Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Clinique Monticelli Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Clinique ophtalmologique du CHU de Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| CHU de Nice - Hôpital Pasteur 2 Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Centre Broca / Mutuelle Generale Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU Pitie Salpetriere Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Fondation Rothschild Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Chu Lariboisiere Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital des 15-20 Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.