- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00312403
Polymorphisms in the Human Matrix Metalloproteinase Genes MMP1, MMP3, and MMP9: Genetic Risk Factors of Primary Open Angle Glaucoma?
January 14, 2010 updated by: Medical University of Vienna
Matrix metalloproteinases (MMPs) fulfill diverse important molecular functions and play pivotal roles in development, tissue morphogenesis, repair, aging, and inflammatory processes.
MMPs are also important disease modulating factors, such as cancer, cardiovascular disease, rheumatoid arthritis or macular degeneration.
Functional genetic variants have been described to fine-tune MMP activities at the gene transcriptional level and have been associated with increased genetic risk of e.g.
arteriosclerosis or cancer.
MMPs are also assumed to play a major role in the remodeling of the extracellular matrix (ECM) in the optic nerve head during glaucomatous optic neuropathy.
MMP-1, MMP-3 and MMP-9 have been shown to be up-regulated in a variety of animal models of glaucoma.
Here, we study three promoter SNPs within the genes encoding three members of the MMP family.
By assessing the prevalence of genetic variants associated with either increased/decreased enzyme activity, we will (i) estimate their contribution to the genetic risk of developing primary open angle glaucoma (POAG) and (ii) investigate the potential role of MMPs in the functional pathology of POAG.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vienna, Austria, 1090
- Department of Clinical Pharmacology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women older than 39 years
- Primary open angle glaucoma as evidenced from characteristic visual field loss and optic disc cupping (POAG group)
- Healthy subjects matched by age, sex and ethnicity to the POAG patients group (control group)
Exclusion Criteria:
- Exfoliation glaucoma, pigmentary glaucoma
- History of acute angle closure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: 1
Patients with primary open angle glaucoma
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A single venous blood sample will be taken (10 ml).
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Other: 2
Age- and sex-matched control subjects
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A single venous blood sample will be taken (10 ml).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Genotyping results and putatively associated odds with occurence of primary open angle glaucoma.
Time Frame: 15 minutes
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15 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gabriele Fuchsjaeger-Mayrl, M.D., Department of Clinical Pharmacology, Medical University of Vienna
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
April 6, 2006
First Submitted That Met QC Criteria
April 6, 2006
First Posted (Estimate)
April 10, 2006
Study Record Updates
Last Update Posted (Estimate)
January 15, 2010
Last Update Submitted That Met QC Criteria
January 14, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPHT-300505
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.