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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00691340
Other study ID # 075-WUK-2008-002
Secondary ID
Status Withdrawn
Phase N/A
First received June 3, 2008
Last updated March 9, 2015
Start date June 2008
Est. completion date August 2011

Study information

Verified date March 2015
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Observational

Clinical Trial Summary

Glaucoma is a worldwide leading cause of blindness. The key feature of this ocular neuropathy is characterized by an excavating optic nerve head. Loss of retinal ganglion cells is the final end point in blinding diseases of the optic nerve such as glaucoma. It is known that neuronal cell death in glaucoma occurs by an apoptotic mechanism. In earlier studies the investigators could demonstrate that the process of apoptosis is reflected in circulating leukocytes by different parameters, like differential mRNA expression and an increased fragmentation of the DNA. Such alterations point out a relationship between cellular stress and apoptotic events.

Based on the results of mRNA-expression the investigators also expect alterations on the protein level.

This study is, therefore, designed to characterize the proteome related to the proteins involved in cell death related pathways.

Thus, the expression pattern of several proteins in leukocytes from patients with primary open angle glaucoma will be analyzed by techniques like Western-blot and tandem mass spectrometry. These samples will be compared with samples from healthy controls. In addition, they will also be compared with samples from patients with Alzheimer's disease. Since glaucoma is a neurodegenerative disease, these patients will be included as positive controls in this study.


Description:

Hypothesis:

Differences in the proteome concerning cell death pathways of glaucoma patients correspond to the differences in the mRNA expression of these patients.

Specific aims:

Characterization of the cellular proteome from human leukocytes of glaucoma patients compared to healthy controls and patients with Alzheimer's disease.

Background:

Glaucoma is a worldwide leading cause of blindness. The key feature of this ocular neuropathy is characterized by an excavating optic nerve head. Loss of retinal ganglion cells is the final end point in blinding diseases of the optic nerve such as glaucoma. It is known that neuronal cell death in glaucoma occurs by an apoptotic mechanism. In earlier studies we could demonstrate that this cell death is reflected in circulating leukocytes by different parameters, like differential mRNA expression, and an increased fragmentation of the DNA. The differences in mRNA expression indicate a close relationship to cellular stress conditions and apoptotic events: increased mRNA expression was detected for p53, 20S proteasome alpha subunit, ABC1 transporter, p21(WAF1/CIP1), 14-3-3 sigma factor, MMP-9 and MMP-14, and TIMP-1.

Based on the assumption that glaucoma patients may differ on the level of their expression for these mRNAs, we expect that similar differences should exist at the protein level.

This study is, therefore, designed to characterize the proteome related to the proteins involved in cell death related pathways.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- German native speakers

- Age between 18-85 years

- Primary open-angle glaucoma (POAG) with and without vasospasm

- An inclusion criterion for one control group is Alzheimer's disease.

Exclusion Criteria:

Any history of:

- Ocular or systemic diseases other than glaucoma or Alzheimer's disease

- Drug or alcohol abuse

- Any condition potentially interfering with the visual field results. Visual fields will be obtained from the chart.

- Mental impairment interfering with the ability to cooperate and understand the purpose of this study.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland University Hospital, Bonn
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