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

March 9, 2026 updated by: AI-Spectral

Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) at Point-of-Care to Identify and Quantify Biomarkers of Non-Exudative Age-Related Macular Degeneration

The goal of this observational clinical study is to learn if DeepMSI AI detects age-related macular degeneration (AMD) biomarkers with sensitivity and specificity equivalent to experienced clinicians in adults over 40 years old. The main questions it aims to answer are:

  • Does DeepMSI AI detect AMD biomarkers with sensitivity equivalent to experienced clinicians?
  • Does DeepMSI AI detect AMD biomarkers with specificity equivalent to experienced clinicians? Participants' eyes will be imaged by MSI-120 and their images will be analyzed for AMD biomarkers by both DeepMSI AI and retina specialists independently.

Researchers will compare retina image analysis from DeepMSI AI with ground truth (clinicians' interpretations) to see if AI achieves equivalency in sensitivity and specificity.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Woodbridge, New Jersey, United States, 07095
        • Recruiting
        • Contact Lens & Vision
        • Contact:
        • Principal Investigator:
          • Stephen Sinclair, MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The study will enroll participants across the planned study sites including primary eye care and eye clinics in the USA. The study will include adults aged 40 years and older who have been previously imaged with retinal imaging instruments, meet all protocol-specified inclusion and exclusion criteria, and provide informed consent.

Description

Inclusion Criteria: AMD subjects:

  1. Subjects over 40 years of age diagnosed for ne AMD
  2. Subject must be able to understand and must sign an IRB-approved ICF
  3. Subject must have minimum of one prior visit to the clinic
  4. Prior imaging must show signs of neAMD (e.g. drusen of different sizes and types with macular pigmentary changes, complete or incomplete retinal pigment epithelium and outer retinal atrophy) at least in one eye

Healthy subjects:

  1. Subjects over 40 years of age have not been diagnosed with any type of AMD and prior imaging that shows no signs of AMD or other types of retinopathies.
  2. A minimum of light perception visual acuity is required to detect the fixation target during imaging.
  3. Two masked clinicians must confirm and categorize them into healthy eyes. -

Exclusion Criteria:

  • Assessed prior to any considerations of inclusion:

    1. Eyes with significant refractive media opacity (e.g. corneal opacity, significant cataract) that prevents adequate imaging
    2. Severe Refractive Error: Extreme high myopia (≥ -10.00D) or hyperopia (≥ +6.00D) that may compromise image quality.
    3. Unstable Ocular Conditions: Active ocular infections, severe uveitis, or status-post ocular trauma
    4. Recent Intraocular Surgery: Patients who have undergone intraocular surgery (e.g., cataract, retinal, or glaucoma surgery) within the past 3 months (except for intravitreal injections for GA therapy).
    5. History or Current Evidence of other types of retinopathy other than neAMD, e.g. Acute Retinal artery or Vein Occlusion, Diabetic Retinopathy, Idiopathic Epiretinal membrane, Myopic Maculopathy, Hypertension Retinopathy etc.
    6. History of Vitrectomy or Scleral Buckling for any kind of Vitreoretinopathy, e.g. Retinal Detachment, Epiretinal Membrane, Proliferative Diabetic Retinopathy etc. that could distort imaging results.
    7. Inability to Maintain Fixation: Including patients with advanced nystagmus, severe amblyopia, or cognitive impairments (dementia) affecting fixation stability.
    8. Severe Dry Eye or Ocular Surface Disease: Conditions that may interfere with imaging quality or patient comfort during the procedure.
    9. Subjects with essential tremor (head and neck tremors or unstable fixation to prevent adequate imaging)
    10. Inability to understand and refusal to sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AMD eyes
Eyes with Drusen and/or GA
Device: Retina imaging device (MSI-120) and AI (DeepMSI AI)
This is single-arm intervention where device use (acquiring retina images with MSI-120 device and analyzing retinal images with the DeepMSI AI) is the primary intervention to assess performance. To eliminate any potential risk to patients, AI outputs from this study will not be disclosed to treating clinicians or participants during the study period.
Healthy eyes
Subjects over 40 years of age have not been diagnosed with any type of AMD and prior imaging that shows no signs of AMD or other types of retinopathies.
Device: Retina imaging device (MSI-120) and AI (DeepMSI AI)
This is single-arm intervention where device use (acquiring retina images with MSI-120 device and analyzing retinal images with the DeepMSI AI) is the primary intervention to assess performance. To eliminate any potential risk to patients, AI outputs from this study will not be disclosed to treating clinicians or participants during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of equivalency in sensitivity and specificity of the DeepMSI AI system compared with experienced clinicians for detection of AMD biomarkers.
Time Frame: through study completion, an average of 6 months
Assessment of equivalency in sensitivity and specificity of the DeepMSI AI system compared with experienced clinicians for detection of AMD biomarkers (including drusen, GA) at the eye level as identified on MSI images, using the consensus of two masked retina experts as the reference standard.
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AI-Spectral

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

September 5, 2026

Study Completion (Estimated)

September 5, 2026

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MultiCentre CS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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