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NCT07446582 · ClinicalTrials.gov registry record
Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) for AMD Biomarker Detection
A clinical trial of Age-Related (Dry) Macular Degeneration, sponsored by AI-Spectral.
- Recruiting
- Registry status
- 1,000
- Enrollment target
- 1
- Study location
NCT07446582: Recruiting study of Age-Related (Dry) Macular Degeneration, sponsored by AI-Spectral.
NCT07446582 is a study of Age-Related (Dry) Macular Degeneration that is actively recruiting participants, run by AI-Spectral. The registered enrollment target is 1,000 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07446582, a study of Age-Related (Dry) Macular Degeneration, is actively recruiting participants, sponsored by AI-Spectral.
- RECRUITING
- Registry status
- 1,000 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Retina imaging device (MSI-120) and AI (DeepMSI AI)
Study Locations (1)
New Jersey
- Contact Lens & Vision - Woodbridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2026-02-01 |
| Est. Completion | 2026-09-05 |
What NCT07446582 shows while recruiting
NCT07446582 is an observational study that tracks outcomes without assigning an intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 1 condition, with Age-Related (Dry) Macular Degeneration appearing as the primary indexed condition, and to 1 intervention - of which Retina imaging device (MSI-120) and AI (DeepMSI AI) is the first listed.
NCT07446582 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT07446582 about?
NCT07446582 is a clinical study titled "Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) for AMD Biomarker Detection". 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...
What is the current status of trial NCT07446582?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2026-02-01. Estimated completion is 2026-09-05.
What conditions does trial NCT07446582 study?
This clinical trial studies the following conditions: Age-Related (Dry) Macular Degeneration.
What interventions are being tested in trial NCT07446582?
The interventions under investigation include: Retina imaging device (MSI-120) and AI (DeepMSI AI) (DEVICE).
Who is sponsoring clinical trial NCT07446582?
This trial is sponsored by AI-Spectral, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07446582 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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