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Image Biomarkers for Progression of AMD (IBPAMD)

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ClinicalTrials.gov Identifier: NCT04537143
Recruitment Status : Withdrawn (Funding for staff no longer available)
First Posted : September 3, 2020
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
Kenneth Marion, Doheny Image Reading Center

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
AMD

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.

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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
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Control
Non-AMD eyes
AMD
AMD eyes



Primary Outcome Measures :
  1. ONH diameter [ Time Frame: 1-2 year FU ]
  2. area of MNV [ Time Frame: 1-2 year FU ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Half control, half AMD eyes
Criteria

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.
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Responsible Party: Kenneth Marion, Program Manager - Research, Doheny Image Reading Center
ClinicalTrials.gov Identifier: NCT04537143    
Other Study ID Numbers: Narcisa
First Posted: September 3, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease Progression
Disease Attributes
Pathologic Processes