Diabetic RetinopathyNCT05806957
Pivotal Trial to Assess the Clinical Performance of Ophthal-360 for the Detection of Diabetic Retinopathy
An observational study of Diabetic Retinopathy, run by Ophthalytics, Inc..
Trial summary
Multicenter, prospective, study to assess the performance of the Ophthal-360 platform in the diagnosis of more-than-mild Diabetic Retinopathy (mtmDR) in diabetic patients with no previous diagnosis of DR. 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?
- Fundus Photography
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 30 Sep 2024
- 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: Adults diagnosed with diabetes at risk for diabetic retinopathy but not previously diagnosed.
Who may be able to join
- Aged at least 22 years old.
- A documented history of Diabetes Mellitus, defined as any of the following:
- Hemoglobin A1c (HbA1c) ≥ 6.5% based on repeated assessments
- Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) based on repeated assessments
- 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)
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- Criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA).
- Willing to undergo fundus photography by up to 4 different methods and/or cameras.
- Has signed a written informed consent form prior to study participation.
Who cannot join
- Diagnosed with uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters.
- Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
- Has a positive history for laser treatment of the retina or injections into either eye, or any history of retinal surgery.
- Is currently participating in another investigational eye study and actively receiving investigational product for DR or Diabetic Macular Edema (DME).
- Has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation).
- Is contraindicated for imaging by fundus imaging systems used in the study:
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- hypersensitive to light
- recently (within 6 months) underwent photodynamic therapy (PDT)
- taking medication that causes photosensitivity
- positive history for angle-closure glaucoma or narrow anterior chamber angles
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pivotal Trial to Assess the Clinical Performance of Ophthal-360
Multicenter, prospective, study to assess the performance of the Ophthal-360 platform in the diagnosis of more-than-mild Diabetic Retinopathy (mtmDR) in diabetic patients with no previous diagnosis of DR.
Read the detailed description
This is a multicenter, prospective study in which 500 adult subjects at risk for DR but never before diagnosed who satisfy all entry criteria will be enrolled at up to 5 primary care sites.
An additional sub-study will be performed on 30 subjects to assess the precision of the algorithm in detecting DR by imaging these subjects multiple times to demonstrate intra- and inter-operator reliability of the algorithm.
All enrolled subjects will undergo retinal imaging by a novice operator with no experience using the fundus cameras listed. Images from each retinal imaging device will be saved to a computer and uploaded to the server for evaluation by the Ophthal-360 service. A report will be generated and archived for the results of each image.
After imaging by the novice operator, each patient will then have their eyes photographed by a professional fundus photographer using standard mydriatic and OCT imaging for macular edema evaluation. These images will be sent to a Fundus Photography Reading Center for final determination and diagnosis. Patients will received the result of the FPRC evaluation, but not be provided the reports generated by the software.
A comparison between the FPRC determination and the software generated report will be performed to evaluate the analytical performance of the algorithm.
- Conditions
- Diabetic Retinopathy
- Being tested
- Fundus Photography
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fundus PhotographyDevice
Subjects will undergo Fundus Photography using FDA approved non-mydriatic fundus cameras and mydriatic camera with OCT
| Study group | Role | What they receive |
|---|---|---|
| Device: Color Fundus Photography with Non-Mydriatic and Mydriatic Cameras | Not described Receives: Device: Fundus Photography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the Ophthal-360 Software to detect diabetic retinopathy in fundus images
Performance of the Ophthal-360 Software when compared to results of evaluation of fundus photographs by qualified experts.
Measured: 1 day
Specificity of the Ophthal-360 Software to detect diabetic retinopathy in fundus images
Performance of the Ophthal-360 Software when compared to ground truth evaluation of fundus photographs by qualified experts.
Measured: 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 Apr 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion30 Sep 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ophthalytics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806957
- Sponsor's protocol ID
- CD0001
- Status last verified
- Apr 2023
- First submitted
- 28 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No individual data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Trial to Assess the Clinical Performance of Ophthal-360
- ClinicalTrials.gov ID
- NCT05806957
- Acronym / sponsor ID
- CD0001
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ophthalytics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 10 Apr 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.
Multicenter, prospective, study to assess the performance of the Ophthal-360 platform in the diagnosis of more-than-mild Diabetic Retinopathy (mtmDR) in diabetic patients with no previous diagnosis of DR.
Detailed description
This is a multicenter, prospective study in which 500 adult subjects at risk for DR but never before diagnosed who satisfy all entry criteria will be enrolled at up to 5 primary care sites.
An additional sub-study will be performed on 30 subjects to assess the precision of the algorithm in detecting DR by imaging these subjects multiple times to demonstrate intra- and inter-operator reliability of the algorithm.
All enrolled subjects will undergo retinal imaging by a novice operator with no experience using the fundus cameras listed. Images from each retinal imaging device will be saved to a computer and uploaded to the server for evaluation by the Ophthal-360 service. A report will be generated and archived for the results of each image.
After imaging by the novice operator, each patient will then have their eyes photographed by a professional fundus photographer using standard mydriatic and OCT imaging for macular edema evaluation. These images will be sent to a Fundus Photography Reading Center for final determination and diagnosis. Patients will received the result of the FPRC evaluation, but not be provided the reports generated by the software.
A comparison between the FPRC determination and the software generated report will be performed to evaluate the analytical performance of the algorithm.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device: Color Fundus Photography with Non-Mydriatic and Mydriatic Cameras | – | Device: Fundus Photography |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with diabetes at risk for diabetic retinopathy but not previously diagnosed.
Key inclusion criteria (9 listed)
- Aged at least 22 years old.
- A documented history of Diabetes Mellitus, defined as any of the following:
- Willing to undergo fundus photography by up to 4 different methods and/or cameras.
- Has signed a written informed consent form prior to study participation.
Key exclusion criteria (10 listed)
- Diagnosed with uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters.
- Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
- Has a positive history for laser treatment of the retina or injections into either eye, or any history of retinal surgery.
- Is currently participating in another investigational eye study and actively receiving investigational product for DR or Diabetic Macular Edema (DME).
- Has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation).
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 |
|---|---|---|
| Fundus PhotographySubjects will undergo Fundus Photography using FDA approved non-mydriatic fundus cameras and mydriatic camera with OCT | Device | Device: Color Fundus Photography with Non-Mydriatic and Mydriatic Cameras |
Primary outcome
Sensitivity of the Ophthal-360 Software to detect diabetic retinopathy in fundus images
Time frame: 1 day
Performance of the Ophthal-360 Software when compared to results of evaluation of fundus photographs by qualified experts.
Specificity of the Ophthal-360 Software to detect diabetic retinopathy in fundus images
Time frame: 1 day
Performance of the Ophthal-360 Software when compared to ground truth evaluation of fundus photographs by qualified experts.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Individual participant dataSharing planned: No. No individual data will be shared.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by Ophthalytics, Inc..
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 9 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 10 Apr 2023. 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 Joshua Freeman (617 320 4668, josh@ophthalytics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the Ophthal-360 Software to detect diabetic retinopathy in fundus images (time frame: 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 10 Apr 2023.