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

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 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.

Study Overview

• Status: Recruiting
• Conditions: Age Related Macular Degeneration

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 Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Gemmy Cheung Professor; Phone Number: +6563224500; Email: gemmy.cheung.c.m@singhealth.com.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • Singapore National Eye Centre/ Singapore Eye Research Institute
    • Contact: Gemmy Cheung Professor; Phone Number: +6563227460; Email: gemmy.cheung.c.m@singhealth.com.sg
  • Singapore, Singapore
    • Recruiting
    • Outram Community Hospital
    • Contact: Lian Leng Low Associate Professor; Phone Number: +6563265872; Email: low.lian.leng@singhealth.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

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).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years

Collaborators and Investigators

• Sponsor: Singapore National Eye Centre
• Collaborators: Singapore Health Services

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2025
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration
• Other Study ID Numbers: 2025-0160

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No