AEYE-DS Software for Diabetic Retinopathy

Overseen By Maxwell Axler, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AEYE Health Inc

Must not be taking: Photosensitivity drugs

Disqualifiers: Vision loss, Macular edema, Retinopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new software, AEYE-DS, designed to detect more than mild diabetic retinopathy, a common eye problem in people with diabetes. The trial evaluates whether the software can accurately diagnose this condition using eye images. Participants with diabetes who have not been diagnosed with diabetic retinopathy and have no significant vision issues are suitable for this trial. Eye images will be taken with different cameras and compared to analyses by eye specialists to assess the software's effectiveness. As an unphased trial, this study allows participants to contribute to innovative research that could enhance early detection of diabetic retinopathy.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking medication that causes photosensitivity (sensitivity to light), you may not be eligible to participate.

What prior data suggests that the AEYE-DS Software Device is safe for detecting diabetic retinopathy?

Research has shown that the AEYE-DS Software safely and effectively detects diabetic retinopathy, a diabetes-related eye condition, by analyzing eye images. This software examines pictures taken by various eye cameras to identify signs of the condition.

The software's safety appears promising. It is non-invasive, meaning it doesn't touch or affect the body directly. Instead, it analyzes images taken by FDA-approved cameras, reducing the risk of physical harm or discomfort.

Additionally, the software accurately detects more-than-mild diabetic retinopathy. Studies have demonstrated a high sensitivity of 93% (correctly identifying 93 out of 100 people with the condition) and a specificity of 91.4% (correctly identifying 91.4 out of 100 people without the condition). These results suggest the software reliably finds the condition without causing harm.

In summary, the AEYE-DS Software offers a safe option for screening diabetic retinopathy, using advanced technology to analyze eye images without any physical contact. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for diabetic retinopathy, which often involve invasive procedures like laser therapy or injections, AEYE-DS Software offers a non-invasive, tech-driven approach. This software analyzes images of the retina taken with specialized cameras to detect signs of the condition, making the process simpler and potentially faster. Researchers are excited because this method could streamline the diagnosis process, allowing for earlier detection and management, ultimately improving patient outcomes.

What evidence suggests that the AEYE-DS Software is effective for diagnosing more than mild Diabetic Retinopathy?

Research has shown that the AEYE-DS Software, used by participants in this trial, effectively detects more-than-mild diabetic retinopathy. In one study, the software correctly identified 93 out of 100 individuals with the condition and accurately recognized 91 out of 100 without it. This indicates the software excels at both detecting diabetic retinopathy and minimizing false alarms. These findings suggest that AEYE-DS could serve as a reliable tool for screening diabetic retinopathy. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with diabetes who may have a condition called Diabetic Retinopathy. Participants will undergo an eye exam where images of their eyes are taken using different cameras. People with certain eye conditions or previous treatments that could affect the study's results cannot join.

Inclusion Criteria

I have been diagnosed with diabetes according to ADA/WHO standards.

Understand the study and volunteer to sign the informed consent

I am 22 years old or older.

Exclusion Criteria

Subject 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)

I cannot undergo certain eye imaging due to light sensitivity, recent PDT, medication causing photosensitivity, a history of specific glaucoma types, or pregnancy.

I have permanent vision problems that can't be fixed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Analysis

Participants undergo eye exams with photographic imaging using various fundoscopy cameras. Images are analyzed by the AEYE-DS software and an independent reading center.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging and analysis

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AEYE-DS Software

Trial Overview The AEYE-DS Software Device is being tested to see if it can accurately detect a level of Diabetic Retinopathy in diabetic patients by analyzing photos of their eyes taken with various fundoscopy cameras, compared to standard readings by professionals.

How Is the Trial Designed?

Group I: AEYE-DS Software Device Experimental Treatment 1 Intervention

Eligible participants will undergo the following procedures: photographic imaging of each eye using various fundoscopy camera devices. Images obtained will be sent to the AEYE-DS software for analysis. Additional photographic and Optical Coherence Tomography (OCT) images will be obtained using a second fundoscopy/OCT camera device. Images obtained will be sent to a professional reading center for analysis. All study subjects will have their pupils dilated using dilation drops.

Who Is Running the Clinical Trial?

AEYE Health Inc

Lead Sponsor

Trials

3

Recruited

1,500+

A. Stein Regulatory Affairs Consulting Ltd.

Collaborator

Trials

1

Recruited

600+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04612868

NCT04612868 | Efficacy and Safety of AEYE-DS Software ... AEYE-DS is a software device developed to increase compliance with diabetic retinopathy screening by automatically detecting more-than-mild diabetic retinopathy ...

2. ophthalmologyscience.org ophthalmologyscience.org/article/S2666-9145(25)00233-7/fulltext

Autonomous Artificial Intelligence in Diabetic Retinopathy ... Among the 310 youth with diabetes aged 5-21, AI diagnosability was 97.5%, sensitivity 85.7%, and specificity 79.3% compared with the reference ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10838904/

Accuracy of Integrated Artificial Intelligence Grading Using ... Type 2 diabetes was present in 95.5% of patients. Diabetic retinopathy severity by RC evaluation was as follows: no DR (3758 eyes [67.3%]), mild NPDR (540 eyes ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666914525002337

Autonomous Artificial Intelligence in Diabetic Retinopathy ... AEYE reports sensitivity of 93.0% and a specificity of 91.4% on desktop cameras in their clinical trials.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06241664

NCT06241664 | Efficacy and Safety of AEYE Diagnostic ... The goal of this clinical trial is to learn about the performance of the AEYE-DS Software Device to automatically detect more than mild Diabetic Retinopathy ( ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K240058.pdf

AEYE Health Inc. Ahava Stein Regulatory Consultant A. Stein AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate retinal images for diagnostic screening to identify ...