Age-Related (Dry) Macular DegenerationNCT07446582
Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) for AMD Biomarker Detection
An observational study of Age-Related (Dry) Macular Degeneration, run by AI-Spectral at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-Related (Dry) Macular Degeneration
- What is being tested?
- Retina imaging device (MSI-120) and AI (DeepMSI AI)
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to 5 Sep 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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. -
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emily Zhang, MD. PhD contact
United States1 site, 1 recruiting
- Recruiting
Contact Lens & Vision
Woodbridge, New Jersey, 07095
John Cruz, 732-855-7950., j.cruz.clvc@gmail.com
Stephen Sinclair, MD.
About this study
Official title: 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.
- Conditions
- Age-Related (Dry) Macular Degeneration
- Being tested
- Retina imaging device (MSI-120) and AI (DeepMSI AI)
- Keywords
- Age-Related Macular Degeneration, AI, Multispectral imaging
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retina imaging device (MSI-120) and AI (DeepMSI AI)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| AMD eyes | Eyes with Drusen and/or GA Receives: Device: Retina imaging device (MSI-120) and AI (DeepMSI AI) | |
| 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. Receives: Device: Retina imaging device (MSI-120) and AI (DeepMSI AI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of equivalency in sensitivity and specificity of the DeepMSI AI system compared with experienced clinicians for detection of AMD biomarkers.
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.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Feb 2026
- Primary completion5 Sep 2026 (estimated)
- Study completion5 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related (Dry) Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- AI-Spectral
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446582
- Sponsor's protocol ID
- MultiCentre CS
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07446582
- Acronym / sponsor ID
- MultiCentre CS
- Conditions
- Age-Related (Dry) Macular Degeneration
- Keywords
- Age-Related Macular Degeneration, AI, Multispectral imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- AI-SpectralIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 5 Sep 2026 (estimated)
- Study completion
- 5 Sep 2026 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMD eyes | – | Device: Retina imaging device (MSI-120) and AI (DeepMSI AI)Eyes with Drusen and/or GA |
| Healthy eyes | – | Device: Retina imaging device (MSI-120) and AI (DeepMSI AI)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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- Assessed prior to any considerations of inclusion:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | AMD eyes, Healthy eyes |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Zhang, MD. PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related (Dry) Macular Degeneration, run by AI-Spectral at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela F. Esfandiarinezhad, PhD (16135816702, angela.f@deepmsi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.