Intelligent Evaluation of Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

— EviRed  

Official title:

Intelligent Evaluation of Diabetic Retinopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04624737
• Other study ID #: APHP200055
• Status: Recruiting
• Start date: December 21, 2020
• Est. completion date: January 21, 2025

Study information

• Verified date: June 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Ramin TADAYONI, MD
• Phone: +33 6 08 56 33 47
• Email: ramin.tadayoni[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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 DR complications as well as to compare prediction by algorithm to that made by ophthalmologists based on the current DR classification

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: January 21, 2025
• Est. primary completion date: December 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

• no previous vitrectomy,

• 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,

• previous treatment with vitrectomy,

• participant is unable or unwilling to comply with study procedures (including foreign language speakers who are not assisted by a native language speaker),

• vulnerable participants (minors, legally detained),

• patients under legal protection (guardianship),

• prisoners or subjects who are involuntarily incarcerated

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Locations

Country	Name	City	State
France	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	Centre Broca / Mutuelle Generale	Paris
France	Chu Lariboisiere	Paris
France	Chu Pitie Salpetriere	Paris
France	Fondation Rothschild	Paris
France	Hôpital des 15-20	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression to severe retinopathy	Progression towards severe diabetic retinopathy form.	month 12
Secondary	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.	3 years
Secondary	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.	3 years