Age Related Macular DegenerationPRIMENCT07653269
Predicting Risk of Progression of Early to Late AMD in the Aging Eye Through Imaging and Multimodal Evaluation
An observational study of Age Related Macular Degeneration, run by Singapore National Eye Centre at 2 sites in Singapore.
Trial summary
The purpose of this research study is to evaluate a new screening procedure for the early detection and monitoring of Age-related Macular Degeneration (AMD) in community settings and community hospital settings, to identify associated risk factors, and develop personalized monitoring strategies for at-risk individuals… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- How many people
- 1,500 participants
- Where
- 2 sitesSingapore
- Study dates
- 18 Oct 2025to 31 Jul 2029
- 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 55 years and older
- All sexes
- Adult, Older adult
Study population: This study will aim for 1500 participants aged ≥ 55 years from SingHealth Community Outreach Programme, other community-based screening initiatives and Outram Community Hospital (OCH).
Who may be able to join
- Adults aged 55 years or older
- No severe systemic illnesses that prevent study participation
- Willing and able to undergo protocol-required procedures for both eyes
- Willing and able to provide written informed consent
Who cannot join
- Systemic disorders that preclude reliable clinical examination or multimodal imaging
- Poor compliance or severe mental illness that hinders participation
- Persons who are unable to give informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore2 sites, 2 recruiting
- Recruiting
Outram Community Hospital
Singapore
Lian Leng Low Associate Professor, +6563265872, low.lian.leng@singhealth.com.sg
- Recruiting
Singapore National Eye Centre/ Singapore Eye Research Institute
Singapore
Gemmy Cheung Professor, +6563227460, gemmy.cheung.c.m@singhealth.com.sg
About this study
Official title: Predicting Risk of Progression of Early to Late AMD in the Aging Eye Through Imaging and Multimodal Evaluation - PRIME Study
The purpose of this research study is to evaluate a new screening procedure for the early detection and monitoring of Age-related Macular Degeneration (AMD) in community settings and community hospital settings, to identify associated risk factors, and develop personalized monitoring strategies for at-risk individuals throughout the 5 years follow up period, which will allow us to establish prevalence, natural history of progression of early AMD in the community.
Read the detailed description
An effective screening programme requires several key components to be successful. First, the natural history of the condition needs to be well understood. Next, a clear threshold for referral must be established and finally, effective intervention must be available to treat the condition in question. In ophthalmology, the most effective screening programme we have is for diabetic retinopathy (DR). Here, the natural history and thresholds are well established, and treatment in the form of pan-retinal photocoagulation is effective in preventing progression to visually threatening DR.
While there is consensus regarding features that predispose to late AMD, at an individual level, risk, rate and pattern of progression remain unpredictable therefore there is a need to develop effective AMD screening. This is in contrast to diabetic retinopathy because the natural history is well understood and the risk of vision loss increases sharply in those with referrable DR. In AMD, this threshold is not yet established.
As there is currently no standardized screening protocol for early AMD, especially in the community-based setting and community hospital settings, our study aims to understand the natural progression of AMD in the elderly and establish a referrable threshold before visually threatening AMD occurs. This will ultimately inform a comprehensive and standardized community-based screening approach for AMD.
- Conditions
- Age Related Macular Degeneration
- Medical subject headings
- Macular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the natural history of AMD in Asian elderly and to identify clinical multimodal imaging, genetic, and metabolomic predictors of progression.
Progression is defined as the change from early signs of AMD to advanced AMD.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start18 Oct 2025
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age Related 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Collaborators
- Singapore Health Services
- Responsible party
- Principal investigator, Gemmy Cheung Chui Ming, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653269
- Sponsor's protocol ID
- 2025-0160
- Acronym
- PRIME
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Forouhari A, Cheung CMG, Leng LL, Gilead N, Chakravarthy U, Teo KYC. Predicting risk of progression of early to late AMD in the aging eye through imaging and multimodal evaluation: PRIME study protocol. PLoS One. 2026 Aug 31;21(8):e0355953. doi: 10.1371/journal.pone.0355953. eCollection 2026.
PubMed 42672000
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Risk of Progression of Early to Late AMD in the Aging Eye Through Imaging and Multimodal Evaluation - PRIME Study
- ClinicalTrials.gov ID
- NCT07653269
- Acronym / sponsor ID
- PRIME / 2025-0160
- Conditions
- Age Related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Singapore National Eye CentreOther government
- Collaborators
- Singapore Health Services
- Study start
- 18 Oct 2025 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 17 Jun 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 purpose of this research study is to evaluate a new screening procedure for the early detection and monitoring of Age-related Macular Degeneration (AMD) in community settings and community hospital settings, to identify associated risk factors, and develop personalized monitoring strategies for at-risk individuals throughout the 5 years follow up period, which will allow us to establish prevalence, natural history of progression of early AMD in the community.
Detailed description
An effective screening programme requires several key components to be successful. First, the natural history of the condition needs to be well understood. Next, a clear threshold for referral must be established and finally, effective intervention must be available to treat the condition in question. In ophthalmology, the most effective screening programme we have is for diabetic retinopathy (DR). Here, the natural history and thresholds are well established, and treatment in the form of pan-retinal photocoagulation is effective in preventing progression to visually threatening DR.
While there is consensus regarding features that predispose to late AMD, at an individual level, risk, rate and pattern of progression remain unpredictable therefore there is a need to develop effective AMD screening. This is in contrast to diabetic retinopathy because the natural history is well understood and the risk of vision loss increases sharply in those with referrable DR. In AMD, this threshold is not yet established.
As there is currently no standardized screening protocol for early AMD, especially in the community-based setting and community hospital settings, our study aims to understand the natural progression of AMD in the elderly and establish a referrable threshold before visually threatening AMD occurs. This will ultimately inform a comprehensive and standardized community-based screening approach for AMD.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will aim for 1500 participants aged ≥ 55 years from SingHealth Community Outreach Programme, other community-based screening initiatives and Outram Community Hospital (OCH).
Key inclusion criteria (4 listed)
- Adults aged 55 years or older
- No severe systemic illnesses that prevent study participation
- Willing and able to undergo protocol-required procedures for both eyes
- Willing and able to provide written informed consent
Key exclusion criteria (3 listed)
- Systemic disorders that preclude reliable clinical examination or multimodal imaging
- Poor compliance or severe mental illness that hinders participation
- Persons who are unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To establish the natural history of AMD in Asian elderly and to identify clinical multimodal imaging, genetic, and metabolomic predictors of progression.
Time frame: 3 years
Progression is defined as the change from early signs of AMD to advanced AMD.
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 18 Jun 2026.
- Derived from this study: PubMed 42672000Forouhari A, Cheung CMG, Leng LL, Gilead N, Chakravarthy U, Teo KYC. Predicting risk of progression of early to late AMD in the aging eye through imaging and multimodal evaluation: PRIME study protocol. PLoS One. 2026 Aug 31;21(8):e0355953. doi: 10.1371/journal.pone.0355953. eCollection 2026.
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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.
2 sites 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, run by Singapore National Eye Centre at 2 sites in Singapore.
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 4 inclusion and 3 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 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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 Gemmy Cheung Professor (+6563224500, gemmy.cheung.c.m@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish the natural history of AMD in Asian elderly and to identify clinical multimodal imaging, genetic, and metabolomic predictors of progression. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07653269, which also lists 1 linked publication.
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 18 Jun 2026.