NCT07446582 · AI-Spectral
Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) for AMD Biomarker Detection
What this study is about
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.
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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.
Interventions
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- AMD subjects:
- 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 Healthy subjects:
- 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.
- Two masked clinicians must confirm and categorize them into healthy eyes. -
Exclusion criteria
- Assessed prior to any considerations of inclusion:
- 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.
- Subjects with essential tremor (head and neck tremors or unstable fixation to prevent adequate imaging)
- Inability to understand and refusal to sign informed consent
Where
- Woodbridge, New Jersey
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 11, 2026 · Source of record for eligibility and locations