- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07653269
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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Gemmy Cheung Professor
- Telefonnummer: +6563224500
- E-mail: gemmy.cheung.c.m@singhealth.com.sg
Studiesteder
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Singapore, Singapore
- Rekruttering
- Singapore National Eye Centre/ Singapore Eye Research Institute
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Kontakt:
- Gemmy Cheung Professor
- Telefonnummer: +6563227460
- E-mail: gemmy.cheung.c.m@singhealth.com.sg
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Singapore, Singapore
- Rekruttering
- Outram Community Hospital
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Kontakt:
- Lian Leng Low Associate Professor
- Telefonnummer: +6563265872
- E-mail: low.lian.leng@singhealth.com.sg
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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To establish the natural history of AMD in Asian elderly and to identify clinical multimodal imaging, genetic, and metabolomic predictors of progression.
Tidsramme: 3 years
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Progression is defined as the change from early signs of AMD to advanced AMD.
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3 years
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025-0160
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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