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IBPAMD: Image Biomarkers for Progression of AMD

Sponsor
Doheny Image Reading Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04537143
Collaborator
(none)
0
Enrollment
24
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To study qualitatively and quantitatively the Imaging Biomarkers (IBs) on Multi-modal Imaging with Novel technologies (MINT), in order to understand their role in prediction of the Age-related Macular Degeneration (AMD) progression in eyes with and without treatment. The understanding of IBs will allow early detection of AMD, prediction of its evolution, and guidance for the best options for stratified/individualized treatment of AMD.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The qualitative studies will explore use of OCT Angiography (OCTA), Swept Source OCT (SS-OCT), Ultra-Wide Field Fluorescein Angiography (UWF-FA), Adaptive Optic Scanning Laser Ophthalmoscopy (AO-SLO), Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO), Retro Mode Imaging (RMI) and other novel technologies for the retinal diagnosis. Morphologic qualitative IBs described in the literature like macular neovascularization pattern, retinal tubulations, choriocapillary preservation, retinal pigment epithelium atrophy, drusen patterns, etc as well as other IBPAMD original IBs classified in morphopathogenic categories like IBs related-to-MNV, IBs related-to-atrophy, IBs related-to macular chorio-retinal architecture, etc are analyzed in granular fashion by multi-modal imaging approach before and after different treatments for AMD.

    The quantitative IBs assessment will be done in dual mode - classic and original to the IBPAMD trial. The lesions are quantitatively assessed on one hand, by using the classic measurements of the greatest diameter, total lesions area, vessels density, fractal dimension, etc, based on the classic concept of measurements expressed in absolute values (mm, mm2 or pixels). The same lesions are quantitatively assessed by using the original IBPAMD algorithm and software (SITE-app) that introduce a new concept in the quantification of the retinal lesions, the assessment of differences reported to the baseline.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Understanding Imaging Biomarkers That Predict the Progression of Age-Related Macular Degeneration on Multi-modal Novel Retinal Technologies
    Anticipated Study Start Date :
    Jan 1, 2021
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Jan 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Control

    Non-AMD eyes
    AMD

    AMD eyes

    Outcome Measures

    Primary Outcome Measures

    1. ONH diameter [1-2 year FU]

    2. area of MNV [1-2 year FU]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • being male or female

    • at least 18 years of age

    • varied ethnic backgrounds (different ethnic groups have different structures of eye anatomy and we must be able to make ethnic subgroups to account for these differences)

    Exclusion Criteria:

    • vulnerable patients

    • patients under 18

    • pregnant (we exclude pregnant women because pregnancy often can alter eye anatomy)

    • economically and educationally disadvantaged

    • decision impaired

    • homeless people.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Doheny Image Reading Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kenneth Marion, Program Manager - Research, Doheny Image Reading Center
    ClinicalTrials.gov Identifier:
    NCT04537143
    Other Study ID Numbers:
    • Narcisa
    First Posted:
    Sep 3, 2020
    Last Update Posted:
    Sep 28, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Sep 28, 2020