Clinical trial NCT04624737: Intelligent Evaluation of Diabetic Retinopathy
Official title: Intelligent Evaluation of Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetic Retinopathy
Keywords: Diabetic retinopathy. .
Diabetes
Artificial intelligence.
Deep learning
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression to severe retinopathy
timeFrame: month 12
Secondary outcomes:
measure: Algorithm performance
timeFrame: 3 years
measure: Comparison of algorithms prediction to human prediction.
timeFrame: 3 years
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Chu Avicenne
city: Bordeaux
country: France
facility: Chu Bordeaux
city: Brest
country: France
facility: Chu Brest
city: Créteil
country: France
facility: Chic Creteil
city: Dijon
country: France
facility: Chu Dijon
city: Lyon
country: France
facility: Chu Lyon Croix Rousse
city: Marseille
country: France
facility: Clinique Monticelli
city: Nantes
country: France
facility: Clinique ophtalmologique du CHU de Nantes
city: Nice
country: France
facility: CHU de NICE HÔPITAL PASTEUR 2
city: Paris
country: France
facility: Chu Lariboisiere
city: Paris
country: France
facility: Centre Broca / Mutuelle Generale
city: Paris
country: France
facility: Chu Pitie Salpetriere
city: Paris
country: France
facility: Fondation Rothschild
city: Paris
country: France
facility: Hôpital des 15-20
Study officials:
References: