AI-enabled multispectral imaging to detect AMD biomarkers.

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

This project will test if DeepMSI AI using multispectral imaging can find AMD biomarkers as accurately as experienced retina specialists in adults over 40.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: AI-Spectral (industry)
• Locations: 1 site (Woodbridge, New Jersey)
• Trial ID: NCT07446582 on ClinicalTrials.gov

What this trial studies

This observational study images eyes using the MSI-120 device and has each image read independently by DeepMSI AI and by masked retina specialists. It enrolls adults over 40, including people with prior imaging evidence of neAMD and healthy controls confirmed by prior imaging. Researchers will compare AI and clinician readings to determine whether DeepMSI achieves equivalent sensitivity and specificity for AMD biomarkers. Eyes with significant media opacity that prevents adequate imaging are excluded.

Who should consider this trial

Good fit: Ideal participants are adults over 40 who have prior imaging showing neAMD in at least one eye or healthy controls with prior imaging confirming no AMD, who can consent and fixate for MSI imaging.

Not a fit: Patients with significant refractive media opacity (for example dense cataract or corneal opacity) that prevents adequate imaging, or those expecting direct treatment benefits, are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, the AI could provide faster, more consistent detection of AMD biomarkers and help broaden screening access.

How similar studies have performed: AI applied to fundus photos and OCT has shown promising accuracy for AMD detection, but applying AI to multispectral imaging like DeepMSI is relatively novel and less validated in large real-world cohorts.

Eligibility criteria

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

Where this trial is running

Woodbridge, New Jersey

• Contact Lens & Vision — Woodbridge, New Jersey, United States (RECRUITING)

Study contacts

• Study coordinator: Angela F. Esfandiarinezhad, PhD

Conditions: Age-Related Macular Degeneration, AI, Multispectral imaging