NCT05752045

Brief Summary

Evolucare OphtAI is a medical device offering automated, artificial intelligence powered, screening capabilities for Diabetic Retinopathy, Diabetic Macular Edema, Glaucoma, ARM and AMD, whose performances will by tested through the OphtAI-EVAL.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,389

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 28, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

January 25, 2023

Last Update Submit

September 25, 2023

Conditions

Diabetic RetinopathyDiabetic Macular EdemaAge-Related Macular DegenerationAge-related MaculopathyGlaucoma

Keywords

OphtAIArtificial intelligenceComputer-aided diagnosisAutomated screeningMedical DeviceDiabetic patientDiabetic RetinopathyDiabetic Macular EdemaAge-Related Macular DegenerationAge-related MaculopathyGlaucomaEvolucare OphtAI

Outcome Measures

Primary Outcomes (1)

  • Referable Diabetic Retinopathy screening sensitivity/specificity

    Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-EOphtha and RDR-OphDiaT\_full algorithms

    1 year

Secondary Outcomes (11)

  • Diabetic retinopathy grading sensitivity/specificity

    1 year

  • Diabetic retinopathy grading + RDR-EOphtha algorithms combination sensitivity/specificity for RDR detection

    1 year

  • Diabetic retinopathy grading + RDR-OphDiaT_full algorithms combination sensitivity/specificity for RDR detection

    1 year

  • Diabetic retinopathy grading + RDR-EOphtha +DME algorithms combination sensitivity/specificity for RDR detection

    1 year

  • Diabetic retinopathy grading + RDR-OphDiaT_full +DME algorithms combination sensitivity/specificity for RDR detection

    1 year

  • +6 more secondary outcomes

Study Arms (1)

Diabetic patient group assessed for multiple eye diseases

OTHER

Each patient eye disease status will be assessed by expert readers so to provide ground truth against which algorithms performances will be assessed

Device: Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device

Interventions

Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical DeviceDEVICE

Double ophthalmological imaging capture of eye fundus with different fundus camera to screen patient for various eye diseases.

Diabetic patient group assessed for multiple eye diseases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The characteristics required for a subject to take part in the research are
  • Male or female over 18,
  • Type 1 or 2 diabetic,
  • Presenting for screening for diabetic retinopathy,
  • Beneficiary of a social security scheme,
  • For whom written consent has been obtained for participation in the protocol.

You may not qualify if:

  • The following characteristics do not allow the subject to take part in the research:
  • Patient with known DR, more severe than "minimal", including having been treated,
  • Any other condition that, in the opinion of the health professionals, may interfere with their ability to complete the study or may present a significant risk,
  • Presence of social, medical and/or psychological factors that may compromise the patient's adherence to the protocol,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Centre Aix Vision

Aix-en-Provence, 13090, France

RECRUITING

CHU Brest

Brest, France

RECRUITING

Centre Ophtalmologique Brétigny Essonne

Brétigny-sur-Orge, 91220, France

RECRUITING

CH SUD Francilien Corbeil Essonne

Corbeil-Essonnes, 91100, France

RECRUITING

Centre d'examens de santé de la CPAM 93

Corbeil-Essonnes, France

RECRUITING

Retinodiab Bourgogne

Dijon, France

RECRUITING

Clinique Honoré Cave

Montauban, France

NOT YET RECRUITING

CHU Nantes

Nantes, 44000, France

ACTIVE NOT RECRUITING

Retinodiab Franche-Comté

Roppe, 90380, France

NOT YET RECRUITING

Diabète Occitanie

Toulouse, 31059, France

RECRUITING

CHU Toulouse

Toulouse, France

RECRUITING

OPHDIAT

Paris, Île-de-France Region, 75000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetic RetinopathyMacular DegenerationGlaucoma

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesRetinal DegenerationOcular Hypertension

Study Officials

  • Aude Couturier, Dr

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ophélie Flageul

CONTACT

02 23 06 11 13o.flageul@slbpharma.com

Laurent Borderie

CONTACT

0762879928l.borderie@evolucare.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Ground truth and Results being obtained in the end of recruitment and imaging collection, there are no effects on participant or care provider. Also, experts won't be aware of AI results and vice versa.
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Imaging and clinical data will be collected from patients to be reviewed by an expert reader group providing ground truth, and the medical device will be tested against this ground truth
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2023

First Posted

March 2, 2023

Study Start

June 28, 2023

Primary Completion

October 1, 2023

Study Completion

March 1, 2024

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(12)