Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04241536
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Association for Innovation and Biomedical Research on Light and Image

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.

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Procedure: Blood draw and urine collection Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 295 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Metabolomics: A Novel Tool for Investigating the Pathogenesis of Age-related Macular Degeneration
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No arm
This is an epidemiologic study. No arms are considered.
Procedure: Blood draw and urine collection
Patients will collect blood and urine for metabolome analysis




Primary Outcome Measures :
  1. comparison of the metabolomic profile of AMD-progressors and non-progressors [ Time Frame: 1 year ]
    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).


Secondary Outcome Measures :
  1. define statistically relevant metabolite changes with potential value as biomarkers of AMD progression [ Time Frame: 1 year ]
    Our hypothesis is that the statistical comparison of the metabolic profiles of AMD-progressors with those of the corresponding final disease stage will allow the identification of potential biomarkers of progression. These may either comprise features (sets of metabolites) common to both groups or distinct features which will form a particular progressors signature.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No exclusion criteria will apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241536


Contacts
Layout table for location contacts
Contact: Patrícia Barreto, MSc 00351239480148 ext 3148 pbarreto@aibili.pt
Contact: Inês Laíns, PhD ineslains@gmail.com

Sponsors and Collaborators
Association for Innovation and Biomedical Research on Light and Image
Layout table for additonal information
Responsible Party: Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier: NCT04241536    
Other Study ID Numbers: AMDMetab
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Association for Innovation and Biomedical Research on Light and Image:
Age-related Macular Degeneration
Metabolomics
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases