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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00312403
Other study ID # OPHT-300505
Secondary ID
Status Completed
Phase N/A
First received April 6, 2006
Last updated January 14, 2010
Start date November 2005
Est. completion date December 2009

Study information

Verified date January 2010
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Ministry for Health and Women
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date December 2009
Est. primary completion date November 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Procedure:
Blood Sample
A single venous blood sample will be taken (10 ml).

Locations

Country Name City State
Austria Department of Clinical Pharmacology Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Genotyping results and putatively associated odds with occurence of primary open angle glaucoma. 15 minutes No
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