Diabetic RetinopathyNCT04627272
AutoDx-DR Prospective Clinical Validation Study Protocol
A study testing AutoDX-DR in people with Diabetic Retinopathy, run by Hill-Rom.
Trial summary
In this study, we will prospectively evaluate the accuracy of a deep-learning based software algorithm in the detection of diabetic retinopathy from 60° wide single-field retinal fundus images. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- AutoDX-DR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,539 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 31 Jul 2021
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A documented diagnosis of diabetes mellitus in accordance with the criteria established by the American Diabetes Association (ADA)7 as indicated by at least one of the following:
- Hemoglobin A1c (HbA1c) > 6.5%
- Fasting Plasma Glucose (FPG; period of fasting must be at least 8 hours) > 126 mg/dL (7.0 mmol/L)
- Oral Glucose Tolerance Test (OGTT) with 2-hour plasma glucose >200 mg/dL (11.1 mmol/L), using the equivalent of an oral 75 g anhydrous glucose dose dissolved in water o Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)
- 22 years of age or older
- Ability to understand the study and sign the informed consent
Who cannot join
- A documented diagnosis of more than mild diabetic retinopathy in the patient record.
- o More than mild diabetic retinopathy shall be defined as moderate NPDR, severe NPDR, proliferative diabetic retinopathy (PDR) or any level of DME; or a documented diabetic eye exam report indicating more than microaneurysms [i.e. presence of intraretinal hemorrhages, venous beading, intraretinal microvascular abnormalities (IRMA,) neovascularization or DME.]
- They report having severe vision loss in both eyes.
- They report a history of laser treatment or surgery of the retina.
- They report that they are currently receiving treatment for DR or DME.
- They report a diagnosis of angle closure glaucoma.
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- They report hypersensitivity to light which makes retinal imaging uncomfortable.
- They are currently pregnant or breastfeeding.
- They report that they have an iris supported intraocular lens or anterior chamber intraocular lens associated with a previous cataract surgery.
- They had a previous pupilloplasty surgery.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Evaluation of the Accuracy of AutoDx-DR, a Software Algorithm That Detects Diabetic Retinopathy From Retinal Images of Individuals With Diabetes
In this study, we will prospectively evaluate the accuracy of a deep-learning based software algorithm in the detection of diabetic retinopathy from 60° wide single-field retinal fundus images.
Read the detailed description
We will obtain 60° wide single-field retinal fundus images from subjects who are diabetic patients in primary care environments (i.e. non-eye care settings, such as internal medicine, family medicine, and endocrinology). The fundus images will be uploaded to the RetinaVue Network software using the AutoDx-DR with Over-read modality, where images are transmitted to both AutoDx-DR and a remote ophthalmologist. AutoDx-DR will generate an initial Refer or Not Refer recommendation and the remote ophthalmologist will provide a detailed diagnostic image interpretation which will be used for patient management and referral during the course of the study. AutoDx-DR can also generate a third output which is "Inadequate for Interpretation". In this case, the images will still be sent to the remote ophthalmologist for interpretation. If the ophthalmologist also cannot interpret the images, the patient will be recommended to have an in-person comprehensive ophthalmologic exam.
Subjects participating in this study will undergo further retinal fundus imaging: four mydriatic, stereoscopic 45° field of view (4W) retinal images and spectral domain optical coherence tomography (SD-OCT) captured with the Reference Standard Camera (i.e. Zeiss Cirrus 600 photo, or other appropriate FDA-cleared imaging device with stereo fundus photography and SD-OCT capability that meets the requirements of the certified fundus photography reading center such as Topcon, Optovue, and Heidelberg). The 4W and SD-OCT imaging will be performed by a certified technician located at or near the enrolling study site. The 4W and SD-OCT images will be interpreted by a certified fundus photography reading center (FPRC) for more than mild DR or any diabetic macular edema. The FPRC's Not Refer/Refer determination will be used as the "gold standard" interpretation in this study.
The AutoDx-DR interpretation of the 60° wide single-field images will be compared to the FPRC "gold standard" interpretation for the Not Refer/Refer recommendation. Accuracy metrics of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR), and negative likelihood ratio (NLR), with 95% confidence intervals will be calculated. All diabetic patients who are attending routine primary care or endocrinology appointments and meet the enrollment criteria will be invited to participate in the study. All study procedures will be performed during a single study visit.
- Conditions
- Diabetic Retinopathy
- Being tested
- AutoDX-DR
- Keywords
- Diabetic Retinopathy
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutoDX-DRDevice
AutoDx-DR provides basic image interpretation for the detection of DR and diabetic macular edema (DME) and a Refer or Not Refer recommendation.
| Study group | Role | What they receive |
|---|---|---|
| AutoDX and Gold Standard | Experimental | A licensed clinician will obtain 60° wide single-field retinal fundus images from subjects who are diabetic patients in primary care environments (i.e. non-eye care settings, such as internal medicine, family medicine, and endocrinology). The fundus images will be uploaded to the RetinaVue Network software using the AutoDx-DR with Over-read modality, where images are transmitted to both AutoDx-DR and a remote ophthalmologist. Subjects participating in this study will undergo further retinal fundus imaging: four mydriatic, stereoscopic 45° field of view (4W) retinal images and spectral domain optical coherence tomography (SD-OCT) captured with the Reference Standard Camera Receives: Device: AutoDX-DR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
The ability of AutoDX-DR to correctly identify those with the disease (true positive rate)
Measured: Each subject will only have one day study visit and will provide the AutoDX-DR and gold standard reading during their one visit.
Specificity
The ability of AutoDX-DR to correctly identify those without the disease (true negative rate)
Measured: Each subject will only have one day study visit and will provide the AutoDX-DR and gold standard reading during their one visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a study to determine the accuracy of AutoDX. All eligible study participants will have a retinal fundus image taken which is then uploaded to the RetinaVue Network. Subjects will also undergo further retinal fundus imaging: four mydriatic, stereoscopic 45° field of view (4W) retinal images and spectral domain optical coherence tomography (SD-OCT) captured with the Reference Standard Camera.
- Masking
- None (open label)
- Enrolment
- 1,539 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hill-Rom
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rho, Inc., ClinEdge
- Responsible party
- Sponsor
- Investigators
- Antonio Piñero-Piloña, MD, Principal investigator, Diabetes Care CenterJoseph Woolley, MD, Principal investigator, Southwest Internal MedicineKeila Hoover, MD, Principal investigator, Hoover Family MedicineQuang Vo, MD, Principal investigator, Dr. Steven Barag, DOPeter Mattar, MD, Principal investigator, Dr. Peter N. Mattar, MDEfrain Soto, MD, Principal investigator, Park Lakes Family MedicineHarish Thakkar, MD, Principal investigator, Southwest Medical ClinicLuis Gonzalez-Orozco, MD, Principal investigator, Clinic of Luis Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627272
- Sponsor's protocol ID
- 60095127
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Accuracy of AutoDx-DR, a Software Algorithm That Detects Diabetic Retinopathy From Retinal Images of Individuals With Diabetes
- ClinicalTrials.gov ID
- NCT04627272
- Acronym / sponsor ID
- 60095127
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetic Retinopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,539 participants (estimated)
- Lead sponsor
- Hill-RomIndustry (pharma, biotech, devices)
- Collaborators
- Rho, Inc., ClinEdge
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 13 Nov 2020 (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.
In this study, we will prospectively evaluate the accuracy of a deep-learning based software algorithm in the detection of diabetic retinopathy from 60° wide single-field retinal fundus images.
Detailed description
We will obtain 60° wide single-field retinal fundus images from subjects who are diabetic patients in primary care environments (i.e. non-eye care settings, such as internal medicine, family medicine, and endocrinology). The fundus images will be uploaded to the RetinaVue Network software using the AutoDx-DR with Over-read modality, where images are transmitted to both AutoDx-DR and a remote ophthalmologist. AutoDx-DR will generate an initial Refer or Not Refer recommendation and the remote ophthalmologist will provide a detailed diagnostic image interpretation which will be used for patient management and referral during the course of the study. AutoDx-DR can also generate a third output which is "Inadequate for Interpretation". In this case, the images will still be sent to the remote ophthalmologist for interpretation. If the ophthalmologist also cannot interpret the images, the patient will be recommended to have an in-person comprehensive ophthalmologic exam.
Subjects participating in this study will undergo further retinal fundus imaging: four mydriatic, stereoscopic 45° field of view (4W) retinal images and spectral domain optical coherence tomography (SD-OCT) captured with the Reference Standard Camera (i.e. Zeiss Cirrus 600 photo, or other appropriate FDA-cleared imaging device with stereo fundus photography and SD-OCT capability that meets the requirements of the certified fundus photography reading center such as Topcon, Optovue, and Heidelberg). The 4W and SD-OCT imaging will be performed by a certified technician located at or near the enrolling study site. The 4W and SD-OCT images will be interpreted by a certified fundus photography reading center (FPRC) for more than mild DR or any diabetic macular edema. The FPRC's Not Refer/Refer determination will be used as the "gold standard" interpretation in this study.
The AutoDx-DR interpretation of the 60° wide single-field images will be compared to the FPRC "gold standard" interpretation for the Not Refer/Refer recommendation. Accuracy metrics of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR), and negative likelihood ratio (NLR), with 95% confidence intervals will be calculated. All diabetic patients who are attending routine primary care or endocrinology appointments and meet the enrollment criteria will be invited to participate in the study. All study procedures will be performed during a single study visit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a study to determine the accuracy of AutoDX. All eligible study participants will have a retinal fundus image taken which is then uploaded to the RetinaVue Network. Subjects will also undergo further retinal fundus imaging: four mydriatic, stereoscopic 45° field of view (4W) retinal images and spectral domain optical coherence tomography (SD-OCT) captured with the Reference Standard Camera.
| Arm | Type | Receives |
|---|---|---|
| AutoDX and Gold Standard | Experimental | Device: AutoDX-DRA licensed clinician will obtain 60° wide single-field retinal fundus images from subjects who are diabetic patients in primary care environments (i.e. non-eye care settings, such as internal medicine, family medicine, and endocrinology). The fundus images will be uploaded to the RetinaVue Network software using the AutoDx-DR with Over-read modality, where images are transmitted to both AutoDx-DR and a remote ophthalmologist. Subjects participating in this study will undergo further retinal fundus imaging: four mydriatic, stereoscopic 45° field of view (4W) retinal images and spectral domain optical coherence tomography (SD-OCT) captured with the Reference Standard Camera |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A documented diagnosis of diabetes mellitus in accordance with the criteria established by the American Diabetes Association (ADA)7 as indicated by at least one of the following:
- Hemoglobin A1c (HbA1c) > 6.5%
- Fasting Plasma Glucose (FPG; period of fasting must be at least 8 hours) > 126 mg/dL (7.0 mmol/L)
- Oral Glucose Tolerance Test (OGTT) with 2-hour plasma glucose >200 mg/dL (11.1 mmol/L), using the equivalent of an oral 75 g anhydrous glucose dose dissolved in water o Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)
Key exclusion criteria (10 listed)
- A documented diagnosis of more than mild diabetic retinopathy in the patient record.
- o More than mild diabetic retinopathy shall be defined as moderate NPDR, severe NPDR, proliferative diabetic retinopathy (PDR) or any level of DME; or a documented diabetic eye exam report indicating more than microaneurysms [i.e. presence of intraretinal hemorrhages, venous beading, intraretinal microvascular abnormalities (IRMA,) neovascularization or DME.]
- They report having severe vision loss in both eyes.
- They report a history of laser treatment or surgery of the retina.
- They report that they are currently receiving treatment for DR or DME.
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 |
|---|---|---|
| AutoDX-DRAutoDx-DR provides basic image interpretation for the detection of DR and diabetic macular edema (DME) and a Refer or Not Refer recommendation. | Device | AutoDX and Gold Standard |
Primary outcome
Sensitivity
Time frame: Each subject will only have one day study visit and will provide the AutoDX-DR and gold standard reading during their one visit.
The ability of AutoDX-DR to correctly identify those with the disease (true positive rate)
Specificity
Time frame: Each subject will only have one day study visit and will provide the AutoDX-DR and gold standard reading during their one visit.
The ability of AutoDX-DR to correctly identify those without the disease (true negative rate)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- 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.
Antonio Piñero-Piloña, MD principal investigator
Diabetes Care Center
Joseph Woolley, MD principal investigator
Southwest Internal Medicine
Keila Hoover, MD principal investigator
Hoover Family Medicine
Questions about this trial
What is this clinical trial studying?
A study testing AutoDX-DR in people with Diabetic Retinopathy, run by Hill-Rom.
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 10 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 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Elizabeth Downs (9893394131, Elizabeth.Downs@hillrom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: Each subject will only have one day study visit and will provide the AutoDX-DR and gold standard reading during their one visit.). The study lists 2 primary outcomes in all. 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 13 Nov 2020.