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

NCT04454190 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1152

Last updated 2024-03-25

No results posted yet for this 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.

Conditions

  • Glaucoma
  • Primary Open Angle Glaucoma
  • Glaucoma, Suspect

Interventions

DIAGNOSTIC_TEST

Collection of genetic material

Blood samples will be processed for extraction of DNA and genotyping. 10 ml of blood will be collected using standard procedures. The samples will be de-identified and receive a masked ID which will correspond to the existing masked ID in the DGR database. 2 ml will be sent to Genentech using frozen samples for genotyping using the Illumina Global Screening Array (GSA) kit. The remaining will be processed and stored at the Duke Eye Center. These samples may be maintained indefinitely or until they are exhausted. These samples will not be available for diagnostic or therapeutic purposes.

Sponsors & Collaborators

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-20
Primary Completion
2023-04-24
Completion
2023-04-24

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT04454190 on ClinicalTrials.gov