Metabolomics: A Novel Tool for Investigating the Pathogenesis of Age-related Macular Degeneration

NCT04241536 | Completed

• 1 other identifier: CEC/010/20
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 1

Brief Summary

The global aim of this project is to expand the knowledge on the multifactorial pathogenesis of AMD. In addition to age, the multifactorial pathogenesis of AMD includes environmental and genetic risk factors. However, how these interact to promote progression remains largely unknown. AMD is a progressive retinal disease characterized by mostly asymptomatic early phases and progression to potentially blinding late forms (choroidal neovascularization or geographic atrophy). Individuals vary in their rate of progression, with some remaining stable for years. The reasons behind this variability, as well as the triggers and mechanisms of AMD progression, are not well understood. Currently, the standard of care for assessment of the risk of progression is solely based on fundus appearance, and is limited in its prediction ability. Our previous work showed that metabolomics enables the identification of specific plasma metabolomic profiles in AMD, which vary with the severity stages. The investigators hypothesize that the plasma and urinary metabolomic profile of subjects who progress over a five-year period (progressors) is distinct from those who remain at the same AMD severity stage (non-progressors). In this proposal, the investigators will follow our existing cohort over five years, comparing the metabolomic profiles of progressors to non-progressors.

Conditions

Age-related Macular Degeneration

Keywords

Age-related Macular Degeneration; Metabolomics

Outcome Measures

Primary Outcomes (1)

• comparison of the metabolomic profile of AMD-progressors and non-progressors

  The hypothesis is that AMD-progressors present a distinct plasma and urine metabolomic profile. For this, metabolites in blood and plasma will be detected in order to determine the metabolome profile.Non-targeted MS analysis will be performed using Ultrahigh Performance Liquid Chromatography-Tandem MS (measurement tool).

  1 year

Secondary Outcomes (1)

• define statistically relevant metabolite changes with potential value as biomarkers of AMD progression

  1 year

Study Arms (1)

No arm

OTHER

This is an epidemiologic study. No arms are considered.

Procedure: Blood draw and urine collection

Interventions

Blood draw and urine collection PROCEDURE

Patients will collect blood and urine for metabolome analysis

No arm

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study population will be derived from a cohort enrolled in a previous prospective study by our group on AMD metabolomics

Sponsors & Collaborators

• Association for Innovation and Biomedical Research on Light and Image: lead

Study Sites (1)

AIBILI

Coimbra, 3000-548, Portugal

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Blood Specimen Collection; Urine Specimen Collection

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 27, 2020
• Study Start: June 1, 2021
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: January 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)