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临床试验/NCT04640649
NCT04640649Unknown不适用

A Novel Approach to Personalized Prediction of Progression of Age-Related Macular Degeneration

University of Illinois at Chicago0 个研究点目标入组 278 人开始时间: 2020年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
278
主要终点
Visual Acuity

研究概览

简要总结

The goal for this study is to initiate a randomized, controlled clinical trial to test the viability of personalized AMD progression prediction models. Early and intermediate AMD patients will be recruited and randomly assigned them to a control or test group. The test group will include patients who will receive personalized follow-up care based on their predicted risk, and collect baseline and follow-up data.

This work will advance the AMD field by improving the identification of high-risk patients as candidates for more frequent screening and earlier treatment, leading to better clinical outcomes.

详细描述

More than 90% of patients with advanced AMD have severe vision loss. Predicting AMD progression from an early or intermediate stage is crucial, since prompt intervention after a choroidal neovascularization (CNV) event and geographic atrophy (GA) monitoring can greatly improve visual outcomes. Patients at higher risk of progression should have more frequent follow-up visits, since progression often occurs before any visual changes are noticed by the patient. Previous work has determined the risk factors for AMD progression based on drusen features in fundus photos, Optical Coherence Tomography (OCT) and from genetic factors. However, current models are limited by their ability to make predictions over short intervals, which limits their utility in guiding screening intervals.

In this study we will recruit patients with early and intermediate AMD in at least one eye who are at risk of converting to wet AMD or GA expansion. We will perform a randomized trial where we will randomly assign them to a control or test group (personalized follow-up care starting at 3 months based on their predicted risk from algorithm results), and collect baseline genetic, demographic, imaging, and clinical data and first follow-up data at the 3 month and 6 month follow-up time points. Outcomes will be measured to determine if an algorithm predicting early follow-up for high-risk patients (3 month) is advantageous over the standard 6 month follow-up time point.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Non-neovascular AMD at baseline in at least one eye with no signs of GA,
  • > 45 years of age,
  • willingness to participate through a signed consent form.

排除标准

  • Pregnant women and vulnerable populations
  • Participation in an investigational trial that involves treatment with any drug (with the exception of vitamins or minerals) within 3 months prior to Day
  • Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid

结局指标

主要结局

Visual Acuity

时间窗: one year

The primary outcome measure will be the difference in visual acuity between test and control patients in those who progressed to late stage AMD

次要结局

  • Actual risk of conversion(one year)
  • Number of visits(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joelle Hallak

Assistant Professor, Director

University of Illinois at Chicago

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