Diabetic RetinopathyNCT03112005
Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool
An observational study of Diabetic Retinopathy and Diabetic Eye Problems, run by Eyenuk, Inc. at 1 site in United States.
Trial summary
More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or diabetic macular edema (DME) collectively known as diabetic eye disease (DED), the leading cause of vision loss and blindness in working-age adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Diabetic Eye Problems, Diabetic Macular Edema
- What is being tested?
- Color fundus photography and Mydriatic Agent
- Type of treatment
- Surgery or procedure
- How many people
- 942 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2017to 31 May 2018
- Phase
- Observational
- 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
Study population: Study subjects will be enrolled at eye care practices and primary/diabetes care practices
Who may be able to join
- A diagnosis of diabetes mellitus;
- Understanding of study and provision of written informed consent; and
- 18 years of age or older.
Who cannot join
- Persistent visual impairment in one or both eyes;
- History of macular edema or retinal vascular (vein or artery) occlusion;
- History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract surgery without complications;
- Subject is contraindicated for fundus photography (for example, has light sensitivity);
- Subject has contraindications for mydriatic medications or is unwilling or unable to dilate;
- Subject is currently enrolled in an interventional study of an investigational device or drug; or
- Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable clinical reference standard photographs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles Biomedical Research Institute
Los Angeles, California, 90502
About this study
More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or diabetic macular edema (DME) collectively known as diabetic eye disease (DED), the leading cause of vision loss and blindness in working-age adults. Annual eye screening is recommended for all diabetic patients since vision loss can be prevented with laser photocoagulation and anti-VEGF treatment if DR is diagnosed in its early stages. Currently, the number of clinical personnel trained for DR screening is orders of magnitude smaller than that needed to screen the large, growing diabetic population. Therefore, to meet this large unmet need for DR screening, a fully-automated computerized DR screening system is necessary.
EyeArt is an automated screening device designed automatically analyze color fundus photographs of diabetic patients to identify patients with referable or vision threatening DED. This study is designed to assess the safety and efficacy of EyeArt.
Read the detailed description
This is a prospective, multi-center, observational study to assess the safety and efficacy of EyeArt in screening for DR.
This study will enroll up to 940 subjects who meet the eligibility criteria at eye care practices and primary/diabetes care practices. Subjects will undergo fundus photography per the EyeArt photography manual using commercially available, Food and Drug Administration (FDA) cleared, non-mydriatic fundus cameras.
Additionally, after dilation, the subject will undergo clinical reference standard photography by photographers certified to obtain photographs for clinical reference standard grading.
The EyeArt screening results on photographs obtained per the EyeArt photography manual will be compared with the clinical reference standard grading to evaluate the sensitivity and specificity of the EyeArt device.
The study will be conducted in accordance with applicable regulatory requirements and established rules for Good Clinical Practice (GCP). Study sites will be chosen to meet the study requirements.
Each study site will be visited periodically by the Study Monitor who will ascertain that all aspects of the Study Protocol are complied with and that the conduct of the study conforms to applicable regulatory requirements and established GCP rules.
At the time of each monitoring visit, the Study Monitor will review the completed case report forms (CRFs) to ascertain that all items have been completed and that the data provided are accurate and obtained in the manner specified in the protocol.
The Study Monitor will also check that the data in the CRF are consistent with the clinical records (Source Data Verification) and that study results are recorded completely and correctly. The Study Monitor will check on the reporting of adverse events (AEs).
All subject data will be captured utilizing a 21 CFR Part 11 compliant database. Electronic case report forms (eCRFs) will be source document verified by designated study monitors. Data entry of subject data will be performed by approved trained Site Personnel. Approved Site Personnel will have a user specific log-in name and password to access the electronic data capture (EDC) system in order to enter study data.
The EyeArt device will be finalized and frozen before the first subject is enrolled and a copy will be placed in a version-controlled system. Evidence that Eyenuk does not have direct access to the study data before data lock will include documentation, logs, and audit reports.
- Being tested
- Color fundus photography, Mydriatic Agent
- Keywords
- Diabetic Eye Disease
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Color fundus photographyProcedure or surgery
Subjects will undergo fundus photography before and after administration of mydriatic agent.
Mydriatic AgentDrug
Subjects will be administered mydriatic medication to dilate their pupils.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subject eyes whose EyeArt results match the reading center grading for identifying referable diabetic eye disease (moderate NPDR or higher on the ICDR scale or surrogate markers for CSME).
The performance of EyeArt will be evaluated using sensitivity and specificity measures.
Measured: 1 visit (1 day)
Number of subject eyes whose EyeArt results match the reading center grading for identifying vision threatening diabetic eye disease (severe NPDR or PDR or surrogate markers for CSME).
The performance of EyeArt will be evaluated using sensitivity and specificity measures.
Measured: 1 visit (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start17 Apr 2017
- Primary completion31 May 2018
- Study completion31 May 2018
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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 942 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyenuk, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112005
- Sponsor's protocol ID
- EN-01
- Other IDs
- 9SB1EY027241, 2R44EY026864
- Status last verified
- Jul 2018
- First submitted
- 7 Apr 2017
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool
- ClinicalTrials.gov ID
- NCT03112005
- Acronym / sponsor ID
- EN-01
- Keywords
- Diabetic Eye Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 942 participants (actual)
- Lead sponsor
- Eyenuk, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Eye Institute (NEI)
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 13 Apr 2017 (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.
More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or diabetic macular edema (DME) collectively known as diabetic eye disease (DED), the leading cause of vision loss and blindness in working-age adults. Annual eye screening is recommended for all diabetic patients since vision loss can be prevented with laser photocoagulation and anti-VEGF treatment if DR is diagnosed in its early stages. Currently, the number of clinical personnel trained for DR screening is orders of magnitude smaller than that needed to screen the large, growing diabetic population. Therefore, to meet this large unmet need for DR screening, a fully-automated computerized DR screening system is necessary.
EyeArt is an automated screening device designed automatically analyze color fundus photographs of diabetic patients to identify patients with referable or vision threatening DED. This study is designed to assess the safety and efficacy of EyeArt.
Detailed description
This is a prospective, multi-center, observational study to assess the safety and efficacy of EyeArt in screening for DR.
This study will enroll up to 940 subjects who meet the eligibility criteria at eye care practices and primary/diabetes care practices. Subjects will undergo fundus photography per the EyeArt photography manual using commercially available, Food and Drug Administration (FDA) cleared, non-mydriatic fundus cameras.
Additionally, after dilation, the subject will undergo clinical reference standard photography by photographers certified to obtain photographs for clinical reference standard grading.
The EyeArt screening results on photographs obtained per the EyeArt photography manual will be compared with the clinical reference standard grading to evaluate the sensitivity and specificity of the EyeArt device.
The study will be conducted in accordance with applicable regulatory requirements and established rules for Good Clinical Practice (GCP). Study sites will be chosen to meet the study requirements.
Each study site will be visited periodically by the Study Monitor who will ascertain that all aspects of the Study Protocol are complied with and that the conduct of the study conforms to applicable regulatory requirements and established GCP rules.
At the time of each monitoring visit, the Study Monitor will review the completed case report forms (CRFs) to ascertain that all items have been completed and that the data provided are accurate and obtained in the manner specified in the protocol.
The Study Monitor will also check that the data in the CRF are consistent with the clinical records (Source Data Verification) and that study results are recorded completely and correctly. The Study Monitor will check on the reporting of adverse events (AEs).
All subject data will be captured utilizing a 21 CFR Part 11 compliant database. Electronic case report forms (eCRFs) will be source document verified by designated study monitors. Data entry of subject data will be performed by approved trained Site Personnel. Approved Site Personnel will have a user specific log-in name and password to access the electronic data capture (EDC) system in order to enter study data.
The EyeArt device will be finalized and frozen before the first subject is enrolled and a copy will be placed in a version-controlled system. Evidence that Eyenuk does not have direct access to the study data before data lock will include documentation, logs, and audit reports.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects will be enrolled at eye care practices and primary/diabetes care practices
Key inclusion criteria (3 listed)
- A diagnosis of diabetes mellitus;
- Understanding of study and provision of written informed consent; and
- 18 years of age or older.
Key exclusion criteria (7 listed)
- Persistent visual impairment in one or both eyes;
- History of macular edema or retinal vascular (vein or artery) occlusion;
- History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract surgery without complications;
- Subject is contraindicated for fundus photography (for example, has light sensitivity);
- Subject has contraindications for mydriatic medications or is unwilling or unable to dilate;
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 |
|---|---|---|
| Color fundus photographySubjects will undergo fundus photography before and after administration of mydriatic agent. | Procedure or surgery | – |
| Mydriatic AgentSubjects will be administered mydriatic medication to dilate their pupils. | Drug | – |
Primary outcome
Number of subject eyes whose EyeArt results match the reading center grading for identifying referable diabetic eye disease (moderate NPDR or higher on the ICDR scale or surrogate markers for CSME).
Time frame: 1 visit (1 day)
The performance of EyeArt will be evaluated using sensitivity and specificity measures.
Number of subject eyes whose EyeArt results match the reading center grading for identifying vision threatening diabetic eye disease (severe NPDR or PDR or surrogate markers for CSME).
Time frame: 1 visit (1 day)
The performance of EyeArt will be evaluated using sensitivity and specificity measures.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy and Diabetic Eye Problems, run by Eyenuk, Inc. at 1 site in United States.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subject eyes whose EyeArt results match the reading center grading for identifying referable diabetic eye disease (moderate NPDR or higher on the ICDR scale or surrogate markers for CSME). (time frame: 1 visit (1 day)). 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 30 Jul 2018.