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Predicting Risk of Progression of Early to Late AMD in the Aging Eye Through Imaging and Multimodal Evaluation

Predicting Risk of Progression of Early to Late AMD in the Aging Eye Through Imaging and Multimodal Evaluation - PRIME Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07653269
Acronym
PRIME
Enrollment
1500
Registered
2026-06-17
Start date
2025-10-18
Completion date
2029-07-31
Last updated
2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age Related Macular Degeneration

Brief 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 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.

Interventions

None listed

Sponsors

Singapore National Eye Centre
Lead SponsorOTHER_GOV
Singapore Health Services
CollaboratorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
To establish the natural history of AMD in Asian elderly and to identify clinical multimodal imaging, genetic, and metabolomic predictors of progression.3 yearsProgression is defined as the change from early signs of AMD to advanced AMD.

Countries

Singapore

Contacts

CONTACTGemmy Cheung Professor
gemmy.cheung.c.m@singhealth.com.sg+6563224500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026