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临床试验/NCT04537143
NCT04537143撤回不适用

Understanding Imaging Biomarkers That Predict the Progression of Age-Related Macular Degeneration on Multi-modal Novel Retinal Technologies

Doheny Image Reading Center0 个研究点开始时间: 2021年1月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
area of MNV

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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.

结局指标

主要结局

area of MNV

时间窗: 1-2 year FU

ONH diameter

时间窗: 1-2 year FU

次要结局

未报告次要终点

研究者

发起方
Doheny Image Reading Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kenneth Marion

Program Manager - Research

Doheny Image Reading Center

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