Age-related Macular Degeneration (AMD)NCT07084883
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
An observational study of Age-related Macular Degeneration (AMD), run by iHealthScreen Inc at 1 site in United States.
Trial summary
The purpose of this study is to perform a pivotal trial of iPredict, an automated AI-based system for early diagnosis and prediction of late AMD in primary care and ophthalmology settings. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-related Macular Degeneration (AMD)
- Type of treatment
- Medical device
- How many people
- 1,076 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 31 Aug 2027
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will be carried at the primary care and general ophthalmology clinic. The total number of patients to be recruited is 1076. Subjects will be recruited during their routine ophthalmology visit, and each subject will be identified by their ophthalmologist as appropriate to take part in the study. After a short verbal explanation, the ophthalmologist may ask the subject to take part in the study. Patients will be recruited without selection by eye diagnosis from the clinics. Both males and females will be invited to participate. Patients will be over 50 since AMD is overwhelmingly a disease of this population. It is anticipated that the subjects will be of all races and ethnic origins, in line with our diverse clinic populations in New York city. Provided that they fit the study criteria, all subjects are invited to participate. However, we aim to recruit the majority as white ethnicity as AMD is a disease for predominantly white ethnicity.
Who may be able to join
- Subjects will be recruited if willing and able to comply with clinic visit and study-related procedures, and provide signed informed consent
Who cannot join
- Already diagnosed with AMD, unable to provide informed consent and currently under treatment of retinal disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
iHealthScreen Inc.
Richmond Hill, New York, 11418
Alauddin Bhuiyan, 718-926-9000, bhuiyan@ihealthscreen.org
About this study
Official title: Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration in Ophthalmology and Primary Care Settings
The purpose of this study is to perform a pivotal trial of iPredict, an automated AI-based system for early diagnosis and prediction of late AMD in primary care and ophthalmology settings. Patients will be invited to participate in this study by having non-dilated photos of their eyes taken by an FDA approved fundus camera (DRSPlus from Centervue Inc., CA), at their primary care doctor's office or general ophthalmologist office. The photos will then be transmitted securely and analyzed by computer in the cloud (telemedicine features). Sufficient accuracy of the automatic system has been established compared to the ophthalmologist's diagnosis. In this study, we aim to validate the system against the prospectively taken OCT image and color fundus images.
Read the detailed description
The purpose of this study is to perform a pivotal trial of iPredict, an automated AI-based system for early diagnosis and prediction of late AMD in primary care and ophthalmology settings. Patients will be invited to participate in this study by having non-dilated photos of their eyes taken by an FDA approved fundus camera (DRSPlus from Centervue Inc., CA), at their primary care doctor's office or general ophthalmologist office. The photos will then be transmitted securely and analyzed by computer in the cloud (telemedicine features). Sufficient accuracy of the automatic system has been established compared to the ophthalmologist's diagnosis. In this study, we aim to validate the system against the prospectively taken OCT image and color fundus images.
Background AMD affects 15 million Americans, with 200,000 new cases diagnosed each year. At present, there is no treatment for dry AMD. Besides blindness, AMD has other indirect complications such as depression, social dependency, and the risk of fall and injury. The prevalence of this disease is expected to grow substantially as life expectancy continues to increase and record numbers of Baby Boomers enter their senior years. The total direct cost of AMD is $220 billion per year and is expected to increase ~1.5 fold. The Age-Related Eye Disease Study (AREDS) showed that specific vitamin supplementation protocols can reduce the risk of progression from intermediate to late AMD by ~25% which in turn could lower the cost of AMD 17.6% if fully implemented. To accomplish this, it is crucial to perform large scale population screening to identify the individuals with early- or intermediate-stage of AMD and better predict those at risk of developing late AMD, but such a system is currently not available. Although articles have been published on automatic AMD pathology detection, none of these systems are available for screening due to lack of validation and commercial readiness. Considering this urgent need, we aim to develop an automated tool iPredict for early diagnosis and prediction of AMD, and make it widely available in both urban and remote/rural areas and for large- scale screening (through its telemedicine features), and thereby prevent blindness.
Primary and Secondary Study Endpoints The accuracy of the iPredict software developed by iHealthScreen system in early diagnosis of AMD using color retinal photos vs. that of human expert graders for AMD. Also, the prediction of late AMD progression in 1 or two years.
- Conditions
- Age-related Macular Degeneration (AMD)
- Being tested
- No intervention.
- Keywords
- Screening, Prediction, age-related macular degeneration, AMD
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention.Device
No intervention. Evaluate the automated AMD screening software.
| Study group | Role | What they receive |
|---|---|---|
| One group | One Cohort Receives: Device: No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Referable and non-referable AMD. And Predict the Incidence of AMD in 1 year or 2-year.
Referable and non-referable AMD. And Predict the Incidence of AMD in 1 year or 2-year.
Measured: 1 year or 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Aug 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular Degeneration (AMD)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,076 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iHealthScreen Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Alauddin Bhuiyan, PhD, Principal investigator, iHealthScreen Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084883
- Sponsor's protocol ID
- 2024-01-iPredict-AMD
- Other IDs
- R44EY031202
- Status last verified
- Nov 2026
- First submitted
- 23 Jul 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In the future we will share the data.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration in Ophthalmology and Primary Care Settings
- ClinicalTrials.gov ID
- NCT07084883
- Acronym / sponsor ID
- 2024-01-iPredict-AMD
- Conditions
- Age-related Macular Degeneration (AMD)
- Keywords
- Screening, Prediction, age-related macular degeneration, AMD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,076 participants (estimated)
- Lead sponsor
- iHealthScreen IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Eye Institute (NEI)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 25 Jul 2025 (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 purpose of this study is to perform a pivotal trial of iPredict, an automated AI-based system for early diagnosis and prediction of late AMD in primary care and ophthalmology settings. Patients will be invited to participate in this study by having non-dilated photos of their eyes taken by an FDA approved fundus camera (DRSPlus from Centervue Inc., CA), at their primary care doctor's office or general ophthalmologist office. The photos will then be transmitted securely and analyzed by computer in the cloud (telemedicine features). Sufficient accuracy of the automatic system has been established compared to the ophthalmologist's diagnosis. In this study, we aim to validate the system against the prospectively taken OCT image and color fundus images.
Detailed description
The purpose of this study is to perform a pivotal trial of iPredict, an automated AI-based system for early diagnosis and prediction of late AMD in primary care and ophthalmology settings. Patients will be invited to participate in this study by having non-dilated photos of their eyes taken by an FDA approved fundus camera (DRSPlus from Centervue Inc., CA), at their primary care doctor's office or general ophthalmologist office. The photos will then be transmitted securely and analyzed by computer in the cloud (telemedicine features). Sufficient accuracy of the automatic system has been established compared to the ophthalmologist's diagnosis. In this study, we aim to validate the system against the prospectively taken OCT image and color fundus images.
Background AMD affects 15 million Americans, with 200,000 new cases diagnosed each year. At present, there is no treatment for dry AMD. Besides blindness, AMD has other indirect complications such as depression, social dependency, and the risk of fall and injury. The prevalence of this disease is expected to grow substantially as life expectancy continues to increase and record numbers of Baby Boomers enter their senior years. The total direct cost of AMD is $220 billion per year and is expected to increase ~1.5 fold. The Age-Related Eye Disease Study (AREDS) showed that specific vitamin supplementation protocols can reduce the risk of progression from intermediate to late AMD by ~25% which in turn could lower the cost of AMD 17.6% if fully implemented. To accomplish this, it is crucial to perform large scale population screening to identify the individuals with early- or intermediate-stage of AMD and better predict those at risk of developing late AMD, but such a system is currently not available. Although articles have been published on automatic AMD pathology detection, none of these systems are available for screening due to lack of validation and commercial readiness. Considering this urgent need, we aim to develop an automated tool iPredict for early diagnosis and prediction of AMD, and make it widely available in both urban and remote/rural areas and for large- scale screening (through its telemedicine features), and thereby prevent blindness.
Primary and Secondary Study Endpoints The accuracy of the iPredict software developed by iHealthScreen system in early diagnosis of AMD using color retinal photos vs. that of human expert graders for AMD. Also, the prediction of late AMD progression in 1 or two years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One group | – | Device: No intervention.One Cohort |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be carried at the primary care and general ophthalmology clinic. The total number of patients to be recruited is 1076. Subjects will be recruited during their routine ophthalmology visit, and each subject will be identified by their ophthalmologist as appropriate to take part in the study. After a short verbal explanation, the ophthalmologist may ask the subject to take part in the study. Patients will be recruited without selection by eye diagnosis from the clinics. Both males and females will be invited to participate. Patients will be over 50 since AMD is overwhelmingly a disease of this population. It is anticipated that the subjects will be of all races and ethnic origins, in line with our diverse clinic populations in New York city. Provided that they fit the study criteria, all subjects are invited to participate. However, we aim to recruit the majority as white ethnicity as AMD is a disease for predominantly white ethnicity.
Key inclusion criteria (1 listed)
- Subjects will be recruited if willing and able to comply with clinic visit and study-related procedures, and provide signed informed consent
Key exclusion criteria (1 listed)
- Already diagnosed with AMD, unable to provide informed consent and currently under treatment of retinal disease.
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 |
|---|---|---|
| No intervention.No intervention. Evaluate the automated AMD screening software. | Device | One group |
Primary outcome
Referable and non-referable AMD. And Predict the Incidence of AMD in 1 year or 2-year.
Time frame: 1 year or 2-year
Referable and non-referable AMD. And Predict the Incidence of AMD in 1 year or 2-year.
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 6 Nov 2026.
- Individual participant dataSharing planned: Yes. In the future we will share the data.
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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.
Alauddin Bhuiyan, PhD principal investigator
iHealthScreen Inc
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 Macular Degeneration (AMD), run by iHealthScreen Inc 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 1 inclusion and 1 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 6 Nov 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 Alauddin Bhuiyan (718-926-9000, bhuiyan@ihealthscreen.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Referable and non-referable AMD. And Predict the Incidence of AMD in 1 year or 2-year. (time frame: 1 year or 2-year). 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 6 Nov 2026.