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NCT04454190 · ClinicalTrials.gov registry record

Development and Validation of a Model to Predict Fast Progression in Glaucoma

A clinical trial, sponsored by Duke University.

Terminated
Registry status
1,152
Enrollment target

NCT04454190: Clinical Trial study, sponsored by Duke University.

NCT04454190 is a clinical trial that was terminated before completion, run by Duke University. The registered enrollment target is 1,152 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04454190 was terminated before completion, sponsored by Duke University.

TERMINATED
Registry status
1,152 participants
Enrollment target

Study Summary

1. The purpose of this study is to obtain genetic data on a well-defined population of patients with glaucoma that had accurate measurements of rates of structural and functional change over time. 2. The investigators aim to recruit 5,000 patients for Phase I and 100 patients for Phase II over a period of 2 years for obtaining blood samples which will be processed for extraction of DNA and genotyping. Phase II also includes eye examination. Patients will be selected from the Duke Glaucoma Registry (DGR) database and will be contacted by phone, mail or email using a standardized script and procedure. 3. Data analysis, based on patient-blind (no personal health information) data will take place at Duke and Genentech. No protected health information (PHI) will leave Duke. Standard statistical methods will be used to analyze the collected data and to develop predictive statistical models for fast progression in glaucoma. Risks from participating in the study are low and include loss of confidentiality and inherent issues related to drawing blood.

Primary Outcome

Rates of change in SAP MD (dB/year) and SD OCT RNFL (µm/year)

Interventions

  • DIAGNOSTIC_TEST Collection of genetic material

Trial Details

FieldValue
Enrollment Target 1,152 participants
Start Date 2021-07-20
Est. Completion 2023-04-24
Duke University

1,725 total trials

Why NCT04454190 stopped before completion

NCT04454190 is an observational study that tracks outcomes without assigning an intervention. Its 1,152 participants enrollment target places it among the larger protocols in the corpus.

The record links to 0 conditions, and to 1 intervention - of which Collection of genetic material is the first listed.

NCT04454190 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04454190 about?

NCT04454190 is a clinical study titled "Development and Validation of a Model to Predict Fast Progression in Glaucoma". 1. The purpose of this study is to obtain genetic data on a well-defined population of patients with glaucoma that had accurate measurements of rates of structural and functional change over time. 2. The investigators aim to recruit 5,000 patients for Phase I and 100 patients for Phase II over a per...

What is the current status of trial NCT04454190?

This trial is currently terminated. The enrollment target is 1,152 participants. The study started on 2021-07-20. Estimated completion is 2023-04-24.

What interventions are being tested in trial NCT04454190?

The interventions under investigation include: Collection of genetic material (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT04454190?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04454190, the US trial registry maintained by the National Library of Medicine. NCT04454190 (large enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.