AEYE-DS Software for Diabetic Retinopathy

No longer recruiting at 2 trial locations

Overseen By Ahava Stein

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AEYE Health Inc

Must not be taking: Photosensitivity drugs

Disqualifiers: Vision loss, Macular edema, Retinopathy, Retinal surgery, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new AI software called AEYE-DS, which helps doctors detect early signs of diabetic retinopathy (eye damage from diabetes) by analyzing eye images. By identifying the condition sooner, it aims to improve screening and treatment rates. The trial seeks adults with diabetes who have not yet been diagnosed with diabetic retinopathy. Participants should not have serious vision issues or other eye conditions that could interfere with the study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance early detection and treatment of diabetic retinopathy.

Will I have to stop taking my current medications?

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), it might be a concern for participation.

What prior data suggests that this software device is safe for diabetic retinopathy screening?

Research has shown that the FDA has approved the AEYE-DS Software to detect more-than-mild diabetic retinopathy, confirming its safety for its intended use. Although detailed safety data from other studies is not available, FDA approval indicates that healthcare providers can safely use the software. This approval suggests the software meets specific safety standards. However, as with any new technology, staying informed about updates or findings from ongoing studies is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for diabetic retinopathy, like laser therapy or anti-VEGF injections, involve direct intervention to manage the condition. However, AEYE-DS Software stands out because it uses artificial intelligence to assist in the early detection of more than mild diabetic retinopathy by analyzing digital images of the retina. This AI-driven approach empowers primary care clinicians to screen for diabetic retinopathy more efficiently and potentially catch the condition earlier than traditional methods. Researchers are excited because this could lead to quicker diagnoses, allowing for earlier treatment and better outcomes for patients with diabetes.

What evidence suggests that this software is effective for diabetic retinopathy?

Research has shown that the AEYE-DS software, which participants in this trial will use, is promising for spotting diabetic retinopathy, an eye condition in people with diabetes. Studies indicate that AI systems like AEYE-DS can accurately detect more-than-mild cases of this condition. One study found that these AI systems correctly identified people with the condition 87-100% of the time and correctly identified those without it about 49-75% of the time. This suggests the software is effective at finding cases of diabetic retinopathy, although it might sometimes mistakenly flag healthy eyes. Overall, AEYE-DS could be a helpful tool for doctors to catch eye problems early in people with diabetes. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

Inclusion Criteria

Understand the study and volunteer to sign the informed consent

You have been diagnosed with diabetes according to the American Diabetes Association and World Health Organization criteria.

You are 22 years old or older.

Exclusion Criteria

You have been diagnosed with diabetic retinopathy in the past.

Participant 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)

Participant is contraindicated for imaging by fundus imaging systems used in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo screening for diabetic retinopathy using the AEYE-DS software device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the use of the AEYE-DS device

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AEYE-DS Software

How Is the Trial Designed?

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

An AI software device (AEYE-DS) to be used as a diagnostic tool to assist primary care clinicians in screening for diabetic retinopathy using digital funduscopic images. The device automatically detects more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy

Who Is Running the Clinical Trial?

AEYE Health Inc

Lead Sponsor

Trials

3

Recruited

1,500+

AEYE Health LLC

Lead Sponsor

Trials

2

Recruited

890+

Published Research Related to This Trial

The MONA.health artificial intelligence screening software demonstrated high diagnostic performance for detecting diabetic retinopathy (DR) and diabetic macular edema (DME), achieving an area under the curve (AUC) of 97.28% for DR and 98.08% for DME on a private test set.

The software maintained strong sensitivity (90.91%) and specificity (94.24%) across various subgroups, although sensitivity was slightly lower for individuals over 65 years old and Caucasians, indicating its effectiveness across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artificial Intelligence Software for Diabetic Eye Screening: Diagnostic Performance and Impact of Stratification. Peeters, F., Rommes, S., Elen, B., et al.[2023]

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 ... The study focused on the 3 currently US Food and Drug Administration-cleared AI systems: LumineticsCore, EyeArt, and AEYE Diagnostic Screening ( ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12419978/

Real-World Evaluation of AI-Driven Diabetic Retinopathy ... The AI algorithms' screening outcomes were inconsistent in providing DR stages (mild nonproliferative diabetic retinopathy (NPDR)), moderate ...

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

Autonomous Artificial Intelligence in Diabetic Retinopathy ... In aggregate, adopters of the AI systems reported average non-mydriatic gradability of 49-75%(n=5), sensitivity 87-100% (n=3), and specificity ...

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/pdf22/K221183.pdf

K221183.pdf - accessdata.fda.gov The AEYE-DS device is indicated for use by health care providers to automatically detect more than mild diabetic retinopathy (mtmDR) in adults ...

7. athenaeumpub.com athenaeumpub.com/artificial-intelligence-systems-for-diabetic-retinopathy-screening-appraisal-on-the-3rd-us-fda-approved-algorithms-aeye-ds-2/

Appraisal on the 3rd US FDA Approved Algorithms The primary outcome measures were performance of the AEYE-DS software for the detection of more than mild Diabetic Retinopathy (mtmDR) on ...