Diabetic RetinopathyOPHTAI-EVALNCT05752045
OphtAI Diagnostic Performance Validation for Automated Screening of Eye Diseases
A study testing Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device in people with Diabetic Retinopathy and Diabetic Macular Edema, run by Evolucare Technologies at 12 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Diabetic Macular Edema, Age-Related Macular Degeneration
- What is being tested?
- Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,389 participants
- Where
- 12 sitesFrance
- Study dates
- 28 Jun 2023to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
- Simultaneously participating in another clinical research protocol or having recently participated in another research study for which the exclusion period would not be completed.
- Patients who participate in this research will not be able to participate in another research at the same time. However, there is no exclusion period at the end of this research for participation in any other study.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites, 11 recruiting
- Recruiting
Centre Aix Vision
Aix-en-Provence, 13090
Sébastien Guigou, Dr, 0442992151, s.guigou@wanadoo.fr
- Recruiting
CHU Brest
Brest
Béatrice Cochener, Pr, beatrice.cochener@ophtalmologie-chu29.fr
Tanguy Thierry, Dr, tbahnguy@gmail.com
- Recruiting
Centre Ophtalmologique Brétigny Essonne
Brétigny-sur-Orge, 91220
Bénédicte Dupas, Dr, 0183639797, dupas@coss.paris
- Recruiting
CH SUD Francilien Corbeil Essonne
Corbeil-Essonnes, 91100
Alfred Penfornis, Pr, 0161697457, alfred.penfornis@chsf.fr
- Recruiting
Centre d'examens de santé de la CPAM 93
Corbeil-Essonnes
Philippe Laboulaye, Dr, 0172595513, philippe.laboulaye@assurance-maladie.fr
- Recruiting
Retinodiab Bourgogne
Dijon
Catherine Creuzot-Garcher, Pr, catherine.creuzot-garcher@chu-dijon.fr
- Not yet recruiting
Clinique Honoré Cave
Montauban
Vincent Gualino, Dr, vincent.gualino@gmail.com
- Active, not recruiting
CHU Nantes
Nantes, 44000
- Not yet recruiting
OPHDIAT
Paris, Île-de-France Region, 75000
Aude Couturier, Dr, aude.couturier@aphp.fr
Ali Erginay, Dr, ali.erginay@aphp.fr
- Not yet recruiting
Retinodiab Franche-Comté
Roppe, 90380
Pierre Bobey, Dr, Pierre_orianne@yahoo.fr
- Recruiting
Diabète Occitanie
Toulouse, 31059
Marie-Christine Chauchard, Dr, chauchard.mc@diabeteoccitanie.org
- Recruiting
CHU Toulouse
Toulouse
Véronique Pagot-Mathis, Dr, pagot-mathis.v@chu-toulouse.fr
Hélène Hanaire, Pr, hanaire.h@chu-toulouse.fr
About this study
Official title: Validation of OphtAI Software Diagnostic Performance for Automated Screening of Diabetic Retinopathy, Diabetic Macular Edema, Glaucoma, ARM and ARMD: a Multicentre Study
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.
Read the detailed description
OphtAI-Eval: is a prospective, multicentre, post-marketing clinical follow-up study (SCAC) of diagnostic validation (comparative vs gold standard).
It aims to: validate the diagnostic performance of the OphtAI software for the automated screening of diabetic retinopathy, diabetic macular edema, glaucoma, ARM and AMD.
Evolucare OphtAI is a medical imaging console for ophthalmology, interfaced with Evolucare Imaging.
It allows the detection, by statistical learning algorithms, of the following ocular pathologies using photographs of the retina:
- Diabetic retinopathy (DR) (including gradation),
- Diabetic macular edema (DME)
- Age-related macular degeneration (AMD)
- Age-related maculopathy (ARM, early form of AMD),
- Glaucoma.
Evolucare OphtAI, is available on the French market since March 2019.
- Conditions
- Diabetic Retinopathy, Diabetic Macular Edema, Age-Related Macular Degeneration, Age-related Maculopathy, Glaucoma
- Being tested
- Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device
- Keywords
- OphtAI, Artificial intelligence, Computer-aided diagnosis, Automated screening, Medical Device, Diabetic patient, Diabetic Retinopathy, Diabetic Macular Edema, Age-Related Macular Degeneration, Age-related Maculopathy, Glaucoma, Evolucare OphtAI
- Medical subject headings
- Diabetic Retinopathy, Macular Degeneration, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (11)
Diabetic retinopathy grading sensitivity/specificity
Diabetic retinopathy grading performance (OphtAI software vs Expert reader) for each grading sub algorithms (sensitivity/specificity) and globally (accuracy/agreement ratio)
Measured: 1 year
Diabetic retinopathy grading + RDR-EOphtha algorithms combination sensitivity/specificity for RDR detection
Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-EOphtha and RD grading algorithms combination
Measured: 1 year
Diabetic retinopathy grading + RDR-OphDiaT_full algorithms combination sensitivity/specificity for RDR detection
Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-OphDiaT_full and RD grading algorithms combination
Measured: 1 year
Diabetic retinopathy grading + RDR-EOphtha +DME algorithms combination sensitivity/specificity for RDR detection
Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-EOphtha, RD grading and DME algorithms combination
Measured: 1 year
Diabetic retinopathy grading + RDR-OphDiaT_full +DME algorithms combination sensitivity/specificity for RDR detection
Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-OphDiaT_full , RD grading and DME algorithms combination
Measured: 1 year
Diabetic Macular Edema algorithm sensitivity/specificityfor DME detection
Diabetic Macular Edema screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for DME algorithm
Measured: 1 year
Age-Related Macular Degeneration algorithm sensitivity/specificity for AMD detection
AMD screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for AMD algorithm, for all forms and for either atrophic or neovascular AMD
Measured: 1 year
Age-Related Maculopathy algorithm ("drusen") sensitivity/specificity for ARM detection
ARM screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for ARM algorithm, for all forms and for either macular or peripheric drusen, or for either hard/soft drusen
Measured: 1 year
Glaucoma algorithms sensitivity/specificity for Glaucoma suspicion
Glaucoma screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for Glaucoma algorithms
Measured: 1 year
Quality algorithm accuracy for quality assessment
Bad quality images sensitivity/specificity evaluation (OphtAI software vs Expert reader) for quality assessment algorithms
Measured: 1 year
Laterality determination algorithm accuracy for laterality assessment
Laterality accuracy of OphtAI software vs Expert reader for laterality determination algorithm
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start28 Jun 2023
- Primary completionOct 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 1,389 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evolucare Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Slb Pharma, Assistance Publique - Hôpitaux de Paris, BPIfrance
- Responsible party
- Sponsor
- Investigators
- Aude Couturier, Dr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752045
- Sponsor's protocol ID
- 2022-A01813-40
- Acronym
- OPHTAI-EVAL
- Status last verified
- Sep 2023
- First submitted
- 25 Jan 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of OphtAI Software Diagnostic Performance for Automated Screening of Diabetic Retinopathy, Diabetic Macular Edema, Glaucoma, ARM and ARMD: a Multicentre Study
- ClinicalTrials.gov ID
- NCT05752045
- Acronym / sponsor ID
- OPHTAI-EVAL / 2022-A01813-40
- Conditions
- Diabetic Retinopathy, Diabetic Macular Edema, Age-Related Macular Degeneration, Age-related Maculopathy, Glaucoma
- Keywords
- OphtAI, Artificial intelligence, Computer-aided diagnosis, Automated screening, Medical Device, Diabetic patient, Diabetic Retinopathy, Diabetic Macular Edema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,389 participants (estimated)
- Lead sponsor
- Evolucare TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Slb Pharma, Assistance Publique - Hôpitaux de Paris, BPIfrance
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OphtAI-Eval: is a prospective, multicentre, post-marketing clinical follow-up study (SCAC) of diagnostic validation (comparative vs gold standard).
It aims to: validate the diagnostic performance of the OphtAI software for the automated screening of diabetic retinopathy, diabetic macular edema, glaucoma, ARM and AMD.
Evolucare OphtAI is a medical imaging console for ophthalmology, interfaced with Evolucare Imaging.
It allows the detection, by statistical learning algorithms, of the following ocular pathologies using photographs of the retina:
- Diabetic retinopathy (DR) (including gradation),
- Diabetic macular edema (DME)
- Age-related macular degeneration (AMD)
- Age-related maculopathy (ARM, early form of AMD),
- Glaucoma.
Evolucare OphtAI, is available on the French market since March 2019.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Diabetic patient group assessed for multiple eye diseases | Other | Device: Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical DeviceEach patient eye disease status will be assessed by expert readers so to provide ground truth against which algorithms performances will be assessed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
- Simultaneously participating in another clinical research protocol or having recently participated in another research study for which the exclusion period would not be completed.
- Patients who participate in this research will not be able to participate in another research at the same time. However, there is no exclusion period at the end of this research for participation in any other study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical DeviceDouble ophthalmological imaging capture of eye fundus with different fundus camera to screen patient for various eye diseases. | Device | Diabetic patient group assessed for multiple eye diseases |
Primary outcome
Referable Diabetic Retinopathy screening sensitivity/specificity
Time frame: 1 year
Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-EOphtha and RDR-OphDiaT_full algorithms
11 secondary outcomes
Diabetic retinopathy grading sensitivity/specificity
Time frame: 1 year
Diabetic retinopathy grading + RDR-EOphtha algorithms combination sensitivity/specificity for RDR detection
Time frame: 1 year
Diabetic retinopathy grading + RDR-OphDiaT_full algorithms combination sensitivity/specificity for RDR detection
Time frame: 1 year
Diabetic retinopathy grading + RDR-EOphtha +DME algorithms combination sensitivity/specificity for RDR detection
Time frame: 1 year
Diabetic retinopathy grading + RDR-OphDiaT_full +DME algorithms combination sensitivity/specificity for RDR detection
Time frame: 1 year
Diabetic Macular Edema algorithm sensitivity/specificityfor DME detection
Time frame: 1 year
Age-Related Macular Degeneration algorithm sensitivity/specificity for AMD detection
Time frame: 1 year
Age-Related Maculopathy algorithm ("drusen") sensitivity/specificity for ARM detection
Time frame: 1 year
Glaucoma algorithms sensitivity/specificity for Glaucoma suspicion
Time frame: 1 year
Quality algorithm accuracy for quality assessment
Time frame: 1 year
Laterality determination algorithm accuracy for laterality assessment
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aude Couturier, Dr principal investigator
Assistance Publique - Hôpitaux de Paris
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device in people with Diabetic Retinopathy and Diabetic Macular Edema, run by Evolucare Technologies at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ophélie Flageul (02 23 06 11 13 ext. 0033, o.flageul@slbpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Referable Diabetic Retinopathy screening sensitivity/specificity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.