Prediction of Progression of Age-Related Macular Degeneration

NCT04640649 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2020-11-23

No results posted yet for this study

Summary

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.

Conditions

  • Macular Degeneration
  • Macular Degeneration, Wet
  • Macular Degeneration, Dry

Interventions

OTHER

Algorithm prediction

Patients with early and intermediate AMD in at least one eye who are at risk of converting to wet AMD or GA expansion will be randomly assigned to a test group or control group. The test group will have their baseline data analyzed by an algorithm to predict the probability of conversion to wet AMD. If the probability is high for conversion at or before 3 months, patients will have earlier follow-up care than the control group (standard follow-up care every 6 months).

Sponsors & Collaborators

  • Stanford University

    collaborator OTHER
  • Illinois Retina Associates

    collaborator OTHER
  • Bascom Palmer Eye Institute

    collaborator OTHER
  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Joelle A Hallak, PhD · University of Illinois at Chicago

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2021-07-31
Completion
2021-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04640649 on ClinicalTrials.gov