Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) for AMD Biomarker Detection (NCT07446582) | Clinical Trial Compass
RecruitingNot Applicable
Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) for AMD Biomarker Detection
United States1,000 participantsStarted 2026-02-01
Plain-language summary
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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects over 40 years of age diagnosed for ne AMD
. Subject must be able to understand and must sign an IRB-approved ICF
. Subject must have minimum of one prior visit to the clinic
. 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
. 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.
. A minimum of light perception visual acuity is required to detect the fixation target during imaging.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of equivalency in sensitivity and specificity of the DeepMSI AI system compared with experienced clinicians for detection of AMD biomarkers.
Timeframe: through study completion, an average of 6 months
. Two masked clinicians must confirm and categorize them into healthy eyes. -
Exclusion criteria
. Eyes with significant refractive media opacity (e.g. corneal opacity, significant cataract) that prevents adequate imaging
. Severe Refractive Error: Extreme high myopia (≥ -10.00D) or hyperopia (≥ +6.00D) that may compromise image quality.
. Unstable Ocular Conditions: Active ocular infections, severe uveitis, or status-post ocular trauma
. 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).
. 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.
. 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.
. Inability to Maintain Fixation: Including patients with advanced nystagmus, severe amblyopia, or cognitive impairments (dementia) affecting fixation stability.
. Severe Dry Eye or Ocular Surface Disease: Conditions that may interfere with imaging quality or patient comfort during the procedure.