What is this study trying to find out about age-related macular degeneration?

This study is evaluating whether the DeepMSI AI system can detect AMD biomarkers as accurately as experienced eye doctors. Researchers want to see if AI analysis of retina images matches clinical assessments. The study is sponsored by AI-Spectral and aims to improve AMD detection using advanced imaging tools.

Who may be eligible for this age-related macular degeneration clinical trial?

Adults aged 40 years or older with or without AMD may be eligible. Participants with AMD should have prior imaging showing AMD signs, while healthy participants must have no AMD or other retinal diseases. Both groups need to be able to undergo retina imaging and provide consent. Please review eligibility criteria for more details.

Is there any cost to participate in this age-related macular degeneration clinical trial?

Study-related care, including the use of the retina imaging device and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can expect to attend scheduled imaging visits during the study period.

Actively Recruiting

Age: 40Years +

All Genders

Healthy Volunteers

ID07446582

Evaluation of AI-Based Multi-Spectral Imaging for Detecting Biomarkers of Dry Age-Related Macular Degeneration in Adults Over 40

Led by AI-Spectral · Updated on 2026-03-11

1000

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether the DeepMSI AI system can detect biomarkers of age-related macular degeneration AMD with sensitivity and specificity comparable to those of experienced clinicians. This observational study focuses on adults over 40 years old and aims to determine if AI analysis of retina images matches clinical interpretations. The study is sponsored by AI-Spectral and seeks to improve AMD detection using advanced imaging technology. Participants eyes will be imaged using the MSI-120 retina imaging device, and the images will be analyzed independently by the DeepMSI AI system and retina specialists. The study includes two groups eyes with AMD-related changes such as drusen or geographic atrophy, and healthy eyes from participants over 40 without any AMD or other retinopathies. AI results will not be shared with participants or treating clinicians during the study to avoid influencing care. Participants will have their retina images collected and analyzed, with researchers comparing AI and clinician findings to assess equivalency in detecting AMD biomarkers. The primary outcome is the comparison of sensitivity and specificity between DeepMSI AI and clinicians over an average follow-up of six months. The study involves no treatment administration, focusing solely on imaging and data collection during the participation period.

CONDITIONS

Brief Title

Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) for AMD Biomarker Detection

Who Can Participate

Age: 40Years +

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Subjects must be over 40 years old
Subjects diagnosed with ne AMD must have prior imaging showing AMD signs in at least one eye
Subjects must be able to understand and sign an IRB-approved consent form
Subjects must have had at least one prior visit to the clinic
Healthy subjects must have no diagnosis of AMD or other retinopathies and prior imaging showing no signs
Healthy subjects must have at least light perception visual acuity to detect the fixation target during imaging
Two masked clinicians must confirm and categorize healthy subjects' eyes as healthy

You will not qualify if you...

Eyes with significant refractive media opacity preventing adequate imaging
Severe refractive errors (high myopia of -10.00D or worse, or hyperopia of +6.00D or worse) that affect image quality
Active ocular infections, severe uveitis, or recent ocular trauma
Intraocular surgery within the past 3 months, except intravitreal injections for GA therapy
History or current evidence of other retinal diseases besides neAMD (e.g., retinal artery/vein occlusion, diabetic retinopathy)
History of vitrectomy or scleral buckling that could distort imaging
Inability to maintain fixation due to conditions like advanced nystagmus, severe amblyopia, or cognitive impairment
Severe dry eye or ocular surface disease affecting imaging or comfort
Essential tremor or unstable fixation preventing adequate imaging
Inability or refusal to understand and sign informed consent

Research Team

Angela F. Esfandiarinezhad, PhD

Emily Zhang, MD. PhD

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Evaluation of AI-Based Multi-Spectral Imaging for Detecting Biomarkers of Dry Age-Related Macular Degeneration in Adults Over 40

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria