DiabetesNCT05368623
Validation Study of RETINA-AI Galaxy™ v2.0, an Automated Diabetic Retinopathy Screening Device
An observational study of Diabetes and Diabetic Retinopathy, run by RETINA-AI Health, Inc. at 3 sites in United States.
Trial summary
Diabetes affects over 37 million Americans and over 530 million people globally. Each diabetic patient needs at least one retinal exam per year starting immediately at the time of diagnosis if they have Type II diabetes (and starting at 5th year after disease onset if they have Type I diabetes). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Diabetes, Diabetic Retinopathy, Diabetic Macular Edema
- What is being tested?
- Color fundus photograph, Optical Coherence Tomography (OCT) of the retina and Mydriatic Agent
- How many people
- 1,100 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Nov 2022to 31 Mar 2023
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study subjects from Primary Care clinics - sampling method: non-probability, invitation to volunteer
Who may be able to join
- Patient age 22 or above
- Patient with a documented diagnosis of diabetes as defined by any of the following:
- Hemoglobin A1c (HbA1c) ≥ 6.5% based on repeated assessments B. Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) based on repeated assessments C. Oral Glucose Tolerance test with 2-hour plasma glucose ≥ 200 mg/dL (11.1mmol/L) using equivalent of 75g anhydrous glucose dose in water.
- Symptoms of hyperglycemia or hyperglycemic crisis with random plasma glucose ≥ 200mg/dL (11.1 mmol/L) E. Criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA).
- Understanding of the Study and willingness and ability to sign informed consent
Who cannot join
- Persistent vision loss in one or both eyes
- Diagnosis with macular edema, severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, radiation retinopathy, or retinal vein occlusion.
- History of retinal laser treatment, or injections into either eye, or any history of retinal surgery.
- Currently enrolled in another interventional study of an investigational device or drug and actively receiving an investigational product for diabetic retinopathy (DR) or Diabetic Macula Edema (DME).
- Subject has contraindication to mydriatic agent (dilating drops) or is unwilling or unable to dilate.
- Subject is contraindicated from fundus photography (e.g. subject is hypersensitive to light).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Clinical Research Organization
Chicago, Illinois, 60402
Clinical Research Organization
Houston, Texas, 77074
Clinical Research Organization
Los Angeles, California, 92844
About this study
Diabetes affects over 37 million Americans and over 530 million people globally. Each diabetic patient needs at least one retinal exam per year starting immediately at the time of diagnosis if they have Type II diabetes (and starting at 5th year after disease onset if they have Type I diabetes). However, majority of diabetic patients do not get their eye exam due to multiple prohibitive factors such as cost, transportation, difficulty of taking time off from work, and inconvenience, amongst others. As a result, diabetes is the most common cause of visual impairment and blindness in working age adults in the United States and globally. Early detection via effective screening can prevent diabetes-related blindness. However, there are multiple barriers to screening. This prompted the development of RETINA-AI Galaxy™ v2.0, an automated Software as a Medical Device that screens for diabetic retinopathy in the primary care setting. This observational study was designed to validate the safety and efficacy of the RETINA-AI Galaxy™ Software-as-a-Medical-Device.
Read the detailed description
This study was a prospective, multicenter, observational study to assess the safety and efficacy of the RETINA-AI Galaxy™ v2.0 ("Galaxy™") in screening for diabetic retinopathy in the primary care setting. The study design conformed to an Intent to Screen (ITS) paradigm. The Galaxy™ is a Software-as-a-Medical-Device designed to analyze digital color fundus photographs and rapidly screen for diabetic retinopathy in the primary care setting.
Subjects who met eligibility criteria were recruited from Sites in the United States staffed by primary care providers. Eligibility was assessed and informed consent was obtained, after which digital color fundus photographs were taken using U.S. Food and Drug Administration (FDA) cleared non-mydriatic fundus cameras, by an operator using the Galaxy photography manual.
There were a total of 3 non-mydriatic robotic screening cameras used in the AI system protocol part of the study. There was a dedicated validation camera used in the Validation Reading Center Protocol part of the study at each Site. Primary care clinical staff (e.g. medical assistant) with no prior professional ophthalmic photography experience and only a 4 hour training operated the RETINA-AI Galaxy v2.0 device and the screening cameras. The Retina Reading Center (RRC)- certified professional ophthalmic photographers operated the validation fundus cameras according the the 4W-D stereo protocol, and obtained OCT images of the macula.
- Being tested
- Color fundus photograph, Optical Coherence Tomography (OCT) of the retina, Mydriatic Agent
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Color fundus photographDiagnostic test
Subjects will undergo color fundus photography before and after pharmacological dilation of pupils.
Optical Coherence Tomography (OCT) of the retinaDiagnostic test
Subjects will undergo OCT of the retina after pharmacological dilation of pupils.
Mydriatic AgentDrug
Pharmacological dilation of pupils will be done by instilling mydriatic agent in eyes of Subjects
| Study group | Role | What they receive |
|---|---|---|
| Sequential Enrollment | Patients aged 22yrs or older who have diabetes will be recruited from primary care settings. Receives: Diagnostic Test: Color fundus photograph; Diagnostic Test: Optical Coherence Tomography (OCT) of the retina; Drug: Mydriatic Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the sensitivity and specificity of RETINA-AI Galaxy v2.0 for diabetic retinopathy screening in the primary care setting.
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 posted10 May 2022
- Study start3 Nov 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- RETINA-AI Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368623
- Sponsor's protocol ID
- RETINA-AI-CT2
- Status last verified
- Oct 2023
- First submitted
- 5 May 2022
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of RETINA-AI Galaxy™ v2.0, an Automated Diabetic Retinopathy Screening Device
- ClinicalTrials.gov ID
- NCT05368623
- Acronym / sponsor ID
- RETINA-AI-CT2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- RETINA-AI Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 10 May 2022 (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.
Diabetes affects over 37 million Americans and over 530 million people globally. Each diabetic patient needs at least one retinal exam per year starting immediately at the time of diagnosis if they have Type II diabetes (and starting at 5th year after disease onset if they have Type I diabetes). However, majority of diabetic patients do not get their eye exam due to multiple prohibitive factors such as cost, transportation, difficulty of taking time off from work, and inconvenience, amongst others. As a result, diabetes is the most common cause of visual impairment and blindness in working age adults in the United States and globally. Early detection via effective screening can prevent diabetes-related blindness. However, there are multiple barriers to screening. This prompted the development of RETINA-AI Galaxy™ v2.0, an automated Software as a Medical Device that screens for diabetic retinopathy in the primary care setting. This observational study was designed to validate the safety and efficacy of the RETINA-AI Galaxy™ Software-as-a-Medical-Device.
Detailed description
This study was a prospective, multicenter, observational study to assess the safety and efficacy of the RETINA-AI Galaxy™ v2.0 ("Galaxy™") in screening for diabetic retinopathy in the primary care setting. The study design conformed to an Intent to Screen (ITS) paradigm. The Galaxy™ is a Software-as-a-Medical-Device designed to analyze digital color fundus photographs and rapidly screen for diabetic retinopathy in the primary care setting.
Subjects who met eligibility criteria were recruited from Sites in the United States staffed by primary care providers. Eligibility was assessed and informed consent was obtained, after which digital color fundus photographs were taken using U.S. Food and Drug Administration (FDA) cleared non-mydriatic fundus cameras, by an operator using the Galaxy photography manual.
There were a total of 3 non-mydriatic robotic screening cameras used in the AI system protocol part of the study. There was a dedicated validation camera used in the Validation Reading Center Protocol part of the study at each Site. Primary care clinical staff (e.g. medical assistant) with no prior professional ophthalmic photography experience and only a 4 hour training operated the RETINA-AI Galaxy v2.0 device and the screening cameras. The Retina Reading Center (RRC)- certified professional ophthalmic photographers operated the validation fundus cameras according the the 4W-D stereo protocol, and obtained OCT images of the macula.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequential Enrollment | – | Diagnostic Test: Color fundus photograph, Diagnostic Test: Optical Coherence Tomography (OCT) of the retina, Drug: Mydriatic AgentPatients aged 22yrs or older who have diabetes will be recruited from primary care settings. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects from Primary Care clinics - sampling method: non-probability, invitation to volunteer
Key inclusion criteria (5 listed)
- Patient age 22 or above
- Patient with a documented diagnosis of diabetes as defined by any of the following:
- Understanding of the Study and willingness and ability to sign informed consent
Key exclusion criteria (6 listed)
- Persistent vision loss in one or both eyes
- Diagnosis with macular edema, severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, radiation retinopathy, or retinal vein occlusion.
- History of retinal laser treatment, or injections into either eye, or any history of retinal surgery.
- Currently enrolled in another interventional study of an investigational device or drug and actively receiving an investigational product for diabetic retinopathy (DR) or Diabetic Macula Edema (DME).
- Subject has contraindication to mydriatic agent (dilating drops) 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 photographSubjects will undergo color fundus photography before and after pharmacological dilation of pupils. | Diagnostic test | Sequential Enrollment |
| Optical Coherence Tomography (OCT) of the retinaSubjects will undergo OCT of the retina after pharmacological dilation of pupils. | Diagnostic test | Sequential Enrollment |
| Mydriatic AgentPharmacological dilation of pupils will be done by instilling mydriatic agent in eyes of Subjects | Drug | Sequential Enrollment |
Primary outcome
To determine the sensitivity and specificity of RETINA-AI Galaxy v2.0 for diabetic retinopathy screening in the primary care setting.
Time frame: 1 visit (1 day)
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 16 Oct 2023.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetic Retinopathy, run by RETINA-AI Health, Inc. at 3 sites 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 5 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: finished, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
To determine the sensitivity and specificity of RETINA-AI Galaxy v2.0 for diabetic retinopathy screening in the primary care setting. (time frame: 1 visit (1 day)). 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 16 Oct 2023.