Development and Validation of a Model to Predict Fast Progression in Glaucoma
Stopped early
Conditions studied: Glaucoma, Primary Open Angle Glaucoma, Glaucoma, Suspect
In brief
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.
Key facts
- Study ID
- NCT04454190
- Run by
- Duke University
- People needed
- 1152
- Starts
- 2021-07-20
- Expected to finish
- 2023-04-24
- Last updated by the study team
- 2024-03-25
Who can join
Age: 40 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
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:
- Inclusion criteria:
- 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.
Where it is running
- Duke University Eye Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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