Study Stopped
PI moved to another institution
Development and Validation of a Model to Predict Fast Progression in Glaucoma
1 other identifier
observational
1,152
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2020
CompletedFirst Posted
Study publicly available on registry
July 1, 2020
CompletedStudy Start
First participant enrolled
July 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2023
CompletedMarch 25, 2024
March 1, 2024
1.8 years
June 29, 2020
March 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rates of change
Rates of change in SAP MD (dB/year) and SD OCT RNFL (µm/year)
1 year
Study Arms (3)
Glaucoma - Slow progressors
Rates of MD change slower than -0.50 dB/year Rates of global RNFL thickness change slower than -1.0 µm/year
Glaucoma - Fast progressors
Rates of MD change faster -0.50 to -2.00 dB/year Rates of global RNFL thickness change -1.0 to -4.0 µm/year
Glaucoma - Catastrophic progressors
Rates of MD change faster than -2.00 dB/year Rates of global RNFL thickness change faster than -4.0 µm/year
Interventions
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.
Eligibility Criteria
The study will involve two phases. Phase I will include patients selected from the Duke Glaucoma Registry (DGR), a database of electronic medical records developed by the Vision, Imaging and Performance (VIP) Laboratory of Dr. Medeiros. The database consists of adults at least 18 years of age with glaucoma or glaucoma suspect diagnoses who were evaluated at the Duke Eye Center or its satellite clinics between 2009 and 2018. Phase II of this study will involve prospective recruitment of subjects with glaucoma for testing and validation of the predictive model from Dr Medeiros's clinic.
You may qualify if:
- \. Subjects will be identified from a previous database search (PRO00103899) with glaucoma or suspicion of glaucoma based on International Classification of Diseases (ICD) codes at baseline.
- Phase II:
- Subjects must be between the ages of 40 and 90 years old;
- Both males and females will be included.
- Be able and willing to provide signed informed consent and follow study instructions
You may not qualify if:
- Subjects will be excluded if they present with any systemic or ocular conditions that in the opinion of the Principal Investigator may prevent them from completing the tests (e.g. history of seizures or pathologies affecting the vestibular system or lower limbs).
- Women of child-bearing potential will be excluded from tests that require pupil dilation, unless they have already received dilating drops as part of their standard of care.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Genentech, Inc.collaborator
Study Sites (1)
Duke University Eye Center
Durham, North Carolina, 27705, United States
Biospecimen
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.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2020
First Posted
July 1, 2020
Study Start
July 20, 2021
Primary Completion
April 24, 2023
Study Completion
April 24, 2023
Last Updated
March 25, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share