Pseudoexfoliation SyndromeNCT00327613
Plasma Levels of Matrix Metalloproteinases (MMPs) and Degree of DNA Fragmentation in Pseudoexfoliation (PEX) Glaucoma
An observational study of Pseudoexfoliation Syndrome and Glaucoma, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pseudoexfoliation Syndrome, Glaucoma
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2005to Apr 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pseudoexfoliation
Who may be able to join
- German native speakers
- Age between 18-80 years
- Pseudoexfoliation syndrome
- Pseudoexfoliation syndrome with open-angle glaucoma
- Primary open-angle glaucoma
Who cannot join
- Any history of ocular or systemic diseases other than glaucoma or of drug or alcohol abuse.
- Any condition potentially interfering with the visual field results. Visual fields will be obtained from the chart.
- Any mentally impaired patient.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Eye Clinic Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Plasma Levels of Matrix Metalloproteinases and Degree of DNA Fragmentation in Patients With Pseudoexfoliation Syndrome and Open-Angle Glaucoma (PEXG)
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 apoptotic mechanism. In earlier studies, the investigators demonstrated that the process of apoptosis is reflected in circulating leukocytes by different parameters, like differential messenger ribonucleic acid (mRNA) expression and an increased fragmentation of the deoxyribonucleic acid (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.
Read more
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 healthy controls. In addition, they will be also compared with samples from patients with Parkinson's disease. Since glaucoma is a neurodegenerative disease, these patients will be included as a positive control in this study.
Read the detailed description
Hypothesis:
Subjects with pseudoexfoliation syndrome in combination with glaucoma may have an altered activity of plasma matrix-metalloproteinase activity and a higher degree of DNA fragmentation in the leukocytes.
Specific aims:
Determination of the level of plasma matrix-metalloproteinase activity and of the degree of DNA fragmentation of leukocytes in patients with pseudoexfoliation syndrome glaucoma (PEX) in comparison to patients with primary open angle glaucoma (POAG).
Background:
One of the main pathogenic factors for the development of glaucoma is an increased intraocular pressure (IOP), which leads to a direct or indirect damage of the nerve fibers in the area of the optic disk. The raise of IOP is based on the increased outflow resistance of the trabecular meshwork due to an excessive accumulation of extracellular material in the juxtacanalicular tissue of the meshwork in eyes with primary open-angle glaucoma (POAG), and an impaired turnover of the trabecular meshwork matrix, which is of paramount importance to the regulation and maintenance of aqueous humor outflow.
Pseudoexfoliation (PEX) syndrome is a systemic disorder of the extracellular matrix, which represents the most common identifiable cause of open-angle glaucoma. There is increasing evidence suggesting that PEX syndrome may be a type of fibrosis associated with excessive synthesis and deposition of an abnormal elastic fibrillar material in many intra- and extraocular tissues. Active involvement of the trabecular meshwork in this abnormal matrix process leading to progressive accumulation of PEX material in the juxtacanalicular tissue is considered to be the primary cause of chronic pressure elevation in eyes with PEX syndrome. However, the mechanisms responsible for this aberrant matrix process remain unknown. Excessive production and accumulation of abnormal matrix components may be due to increased de-novo synthesis, decreased turnover of matrix components, or both.
Extracellular matrix turnover is mediated by matrix metalloproteinases (MMPs), a large family of endopeptidases with variable substrate spectra, the presence of which has been described in human aqueous humor.
The activity of these enzymes is regulated in part by specific endogenous inhibitors, the tissue inhibitors of metalloproteinases (TIMPs). Dysregulated expression of MMPs and TIMPs has been implicated in many disease processes accompanied by abnormal matrix production, such as fibrotic disorders, and a variety of other disease states. In the eye, abnormal expression of MMPs has been implicated, among many other disorders, in glaucoma, in proliferative vitreoretinopathy, secondary cataract formation, and the pathogenesis of pterygia. Therefore, MMPs and TIMPs are likely candidates to be involved in the abnormal extracellular matrix metabolism characteristic of PEX syndrome/glaucoma (PEXG) and POAG.
PEX seems to be an independent risk factor for glaucoma. Possibly, this may be due to an altered perfusion. So, PEX syndrome represents not only the most common identifiable cause of open-angle glaucoma, but also a risk factor for cardiovascular diseases. PEX syndrome and iris trans-illumination defects are seen in patients with transient ischemic attacks. At the microcirculatory level, ischemia/reperfusion (I/R) injury is thought to be initiated by chemotactic accumulation of circulating leukocytes, their activation and interaction with the endothelium of postcapillary venules. In addition, oxygen free radicals are thought to play a pivotal role in the pathogenesis of I/R injury. A variety of experimental models of ischemic injury have shown that free radicals induce post-ischemic oxidative damage to DNA. Although several human studies have revealed that oxygen radicals generated by other mechanisms like irradiation, only few data exist that demonstrate the influence of reperfusion-associated oxygen radicals on DNA in humans. We hypothesize that the pathogenic processes in PEX may be reflected in leukocytes.
Depending on the results that glaucoma patients differ on the level of their mRNA expression for various MMPs in peripheral leukocytes and that PEX syndrome is often seen with transient ischemic attacks, we assume differences in the activity of MMPs in the plasma as well as changes in the DNA stability in peripheral leukocytes of patients with PEX glaucoma.
This study is, therefore, designed to analyze the activity of gelatinases (MMP-2 and -9) in plasma and the degree of DNA fragmentation in peripheral leukocytes of patients with PEX syndrome and PEXG compared to POAG and controls.
- Conditions
- Pseudoexfoliation Syndrome, Glaucoma
- Keywords
- PEX, glaucoma, MMP, DNA degradation, POAG, Healthy subjects
- Medical subject headings
- Exfoliation Syndrome, Glaucoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study startJun 2005
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudoexfoliation SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Selim Orgül, MD, Study director, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327613
- Sponsor's protocol ID
- 066-WUK-2005-001
- Status last verified
- Sep 2008
- First submitted
- 17 May 2006
- Last updated
- 26 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Levels of Matrix Metalloproteinases and Degree of DNA Fragmentation in Patients With Pseudoexfoliation Syndrome and Open-Angle Glaucoma (PEXG)
- ClinicalTrials.gov ID
- NCT00327613
- Acronym / sponsor ID
- 066-WUK-2005-001
- Conditions
- Pseudoexfoliation Syndrome, Glaucoma
- Keywords
- PEX, glaucoma, MMP, DNA degradation, POAG, Healthy subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 18 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 apoptotic mechanism. In earlier studies, the investigators demonstrated that the process of apoptosis is reflected in circulating leukocytes by different parameters, like differential messenger ribonucleic acid (mRNA) expression and an increased fragmentation of the deoxyribonucleic acid (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 healthy controls. In addition, they will be also compared with samples from patients with Parkinson's disease. Since glaucoma is a neurodegenerative disease, these patients will be included as a positive control in this study.
Detailed description
Hypothesis:
Subjects with pseudoexfoliation syndrome in combination with glaucoma may have an altered activity of plasma matrix-metalloproteinase activity and a higher degree of DNA fragmentation in the leukocytes.
Specific aims:
Determination of the level of plasma matrix-metalloproteinase activity and of the degree of DNA fragmentation of leukocytes in patients with pseudoexfoliation syndrome glaucoma (PEX) in comparison to patients with primary open angle glaucoma (POAG).
Background:
One of the main pathogenic factors for the development of glaucoma is an increased intraocular pressure (IOP), which leads to a direct or indirect damage of the nerve fibers in the area of the optic disk. The raise of IOP is based on the increased outflow resistance of the trabecular meshwork due to an excessive accumulation of extracellular material in the juxtacanalicular tissue of the meshwork in eyes with primary open-angle glaucoma (POAG), and an impaired turnover of the trabecular meshwork matrix, which is of paramount importance to the regulation and maintenance of aqueous humor outflow.
Pseudoexfoliation (PEX) syndrome is a systemic disorder of the extracellular matrix, which represents the most common identifiable cause of open-angle glaucoma. There is increasing evidence suggesting that PEX syndrome may be a type of fibrosis associated with excessive synthesis and deposition of an abnormal elastic fibrillar material in many intra- and extraocular tissues. Active involvement of the trabecular meshwork in this abnormal matrix process leading to progressive accumulation of PEX material in the juxtacanalicular tissue is considered to be the primary cause of chronic pressure elevation in eyes with PEX syndrome. However, the mechanisms responsible for this aberrant matrix process remain unknown. Excessive production and accumulation of abnormal matrix components may be due to increased de-novo synthesis, decreased turnover of matrix components, or both.
Extracellular matrix turnover is mediated by matrix metalloproteinases (MMPs), a large family of endopeptidases with variable substrate spectra, the presence of which has been described in human aqueous humor.
The activity of these enzymes is regulated in part by specific endogenous inhibitors, the tissue inhibitors of metalloproteinases (TIMPs). Dysregulated expression of MMPs and TIMPs has been implicated in many disease processes accompanied by abnormal matrix production, such as fibrotic disorders, and a variety of other disease states. In the eye, abnormal expression of MMPs has been implicated, among many other disorders, in glaucoma, in proliferative vitreoretinopathy, secondary cataract formation, and the pathogenesis of pterygia. Therefore, MMPs and TIMPs are likely candidates to be involved in the abnormal extracellular matrix metabolism characteristic of PEX syndrome/glaucoma (PEXG) and POAG.
PEX seems to be an independent risk factor for glaucoma. Possibly, this may be due to an altered perfusion. So, PEX syndrome represents not only the most common identifiable cause of open-angle glaucoma, but also a risk factor for cardiovascular diseases. PEX syndrome and iris trans-illumination defects are seen in patients with transient ischemic attacks. At the microcirculatory level, ischemia/reperfusion (I/R) injury is thought to be initiated by chemotactic accumulation of circulating leukocytes, their activation and interaction with the endothelium of postcapillary venules. In addition, oxygen free radicals are thought to play a pivotal role in the pathogenesis of I/R injury. A variety of experimental models of ischemic injury have shown that free radicals induce post-ischemic oxidative damage to DNA. Although several human studies have revealed that oxygen radicals generated by other mechanisms like irradiation, only few data exist that demonstrate the influence of reperfusion-associated oxygen radicals on DNA in humans. We hypothesize that the pathogenic processes in PEX may be reflected in leukocytes.
Depending on the results that glaucoma patients differ on the level of their mRNA expression for various MMPs in peripheral leukocytes and that PEX syndrome is often seen with transient ischemic attacks, we assume differences in the activity of MMPs in the plasma as well as changes in the DNA stability in peripheral leukocytes of patients with PEX glaucoma.
This study is, therefore, designed to analyze the activity of gelatinases (MMP-2 and -9) in plasma and the degree of DNA fragmentation in peripheral leukocytes of patients with PEX syndrome and PEXG compared to POAG and controls.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pseudoexfoliation
Key inclusion criteria (5 listed)
- German native speakers
- Age between 18-80 years
- Pseudoexfoliation syndrome
- Pseudoexfoliation syndrome with open-angle glaucoma
- Primary open-angle glaucoma
Key exclusion criteria (3 listed)
- Any history of ocular or systemic diseases other than glaucoma or of drug or alcohol abuse.
- Any condition potentially interfering with the visual field results. Visual fields will be obtained from the chart.
- Any mentally impaired patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selim Orgül, MD study director
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudoexfoliation Syndrome and Glaucoma, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2008.