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Polymorphisms in the Human Matrix Metalloproteinase Genes MMP1, MMP3, and MMP9: Genetic Risk Factors of Primary Open Angle Glaucoma?

Primary Purpose

Glaucoma

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Blood Sample

Sponsored by

Medical University of Vienna

About this trial

This is an interventional diagnostic trial for Glaucoma focused on measuring Glaucoma, Gene Polymorphism, Metalloproteinase

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Clinical Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

Patients with primary open angle glaucoma

Age- and sex-matched control subjects

Outcomes

Primary Outcome Measures

Genotyping results and putatively associated odds with occurence of primary open angle glaucoma.

Secondary Outcome Measures

Full Information

NCT ID

First Posted

April 6, 2006

Last Updated

January 14, 2010

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT00312403

Brief Title

Polymorphisms in the Human Matrix Metalloproteinase Genes MMP1, MMP3, and MMP9: Genetic Risk Factors of Primary Open Angle Glaucoma?

Official Title

Polymorphisms in the Human Matrix Metalloproteinase Genes MMP1, MMP3, and MMP9: Genetic Risk Factors of Primary Open Angle Glaucoma?

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Completed

Study Start Date

November 2005 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

Glaucoma, Gene Polymorphism, Metalloproteinase

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Other

Arm Description

Patients with primary open angle glaucoma

Arm Title

2

Arm Type

Other

Arm Description

Age- and sex-matched control subjects

Intervention Type

Procedure

Intervention Name(s)

Blood Sample

Intervention Description

A single venous blood sample will be taken (10 ml).

Primary Outcome Measure Information:

Title

Genotyping results and putatively associated odds with occurence of primary open angle glaucoma.

Time Frame

15 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gabriele Fuchsjaeger-Mayrl, M.D.

Organizational Affiliation

Department of Clinical Pharmacology, Medical University of Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Clinical Pharmacology

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

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Polymorphisms in the Human Matrix Metalloproteinase Genes MMP1, MMP3, and MMP9: Genetic Risk Factors of Primary Open Angle Glaucoma?

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