Macular DegenerationNCT00465400
Oxidative Stress in Patients With Age-Related Macular Degeneration
An observational study of Macular Degeneration, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
First, to quantify, by means of comet assay analysis, systemic oxidative stress in patients with non-exudative and exudative age-related macular degeneration (AMD) and compare results to healthy controls. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Macular Degeneration
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2006to Dec 2007
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with macular degeneration
Who may be able to join
- For patients with dry non- exudative AMD:
- Patients between the ages of 50 and 85 yr inclusive.
- Study eye must have a diagnosis of nonexudative "dry" AMD with ≥10 large soft, semisoft, and/or confluent drusen within 3,000 nm of the foveal center.
- Study eye must have a best corrected visual acuity using the ETDRS chart between 0.1 patem and 0.8 patem inclusive.
- Geographic atrophy is allowed as long as it is less than 3 disc diameters within 3,000 nm of the foveal center.
- Study eye must not have conditions that limit the view of the fundus.
Show all 17Show fewer
- For patients with exudative AMD with clinical indication for PDT treatment:
- Patients between the ages of 50 and 85 yrs with exudative AMD with clinical indication for PDT treatment.
- Primary or recurrent subfoveal CNV due to AMD
- Central 1-mm retinal thickness (optical coherence tomography) > 300 um
- Best-corrected visual acuity, using ETDRS charts, of > 0.05patem
- Evidence of recent disease progression, including the loss of at least 1 line of visual acuity or macular hemorrhage within the previous 12 wks.
- For healthy subjects:
- An intraocular pressure < 20 mmHg
- Normal blood pressure (100-140/60-90mm Hg)
- Best corrected visual acuity, using EDTRS charts of above 0.6 patem in both eyes
- No pathological findings upon slit-lamp examination and indirect fundoscopy
Who cannot join
- History of other ocular or systemic disease
- History of chronic or current systemic or topical medication, or of significant drug or alcohol abuse(significant is defined as that which may influence results of the study
- History of ocular trauma or intraocular surgery within the past 6 months
- History of infection or inflammation within the past 3 months
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: Quantification of Oxidative Stress in Patients With Age-Related Macular Degeneration Prior to and After Photodynamic Therapy: a Comet Assay Analysis
First, to quantify, by means of comet assay analysis, systemic oxidative stress in patients with non-exudative and exudative age-related macular degeneration (AMD) and compare results to healthy controls.
Second, to quantify systemic oxidative stress in patients with exudative AMD prior to and after photodynamic (PDT) therapy.
Read the detailed description
Oxidative stress is the major factor that plays a role in the pathogenesis of age-related macular degeneration (AMD), which is a leading cause of blind registration in the developed world. The term oxidative stress refers to reversible damage to molecules, such as for example DNA, by reactive forms of oxygen (eg. free oxygen radicals). This damage is repaired is normally repaired in our body.
AMD is classified in two forms: the dry (non-exudative) and wet (exudative) form. The exudative form of AMD occurs when new blood vessels form to improve the blood supply to retinal tissue. However, the new blood vessels are very delicate and break easily, causing bleeding and serious vision loss. The standardized method used to treat exudative AMD is photodynamic therapy (PDT). This treatment is based upon the infusion of a drug that can be activated by light and produces free radicals that destroy these newly formed vessels. In other words, these new vessels are destroyed by an iatrogenic source of oxidative stress. This means that the factor that originally caused the disease AMD, namely oxidative stress, is finally used as a form of treatment- to destroy these newly formed blood vessels.
In the present study we would like to quantify in a first step the level of systemic oxidative stress in patients with non-exudative and exudative AMD and compare to healthy controls. In a second step we would like to test whether the treatment (PDT) for patients with exudative AMD additionally increases systemic oxidative stress. Oxidative stress is quantified in our laboratory by means of single cell gel electrophoresis or comet assay.
- Conditions
- Macular Degeneration
- Keywords
- exudative age-related macular degeneration (AMD), non-exudative age-related macular degeneration (AMD), oxidative stress, photodynamic therapy
- Medical subject headings
- Macular Degeneration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startNov 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Macular DegenerationStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Selim Orgül, MD, Study director, University Eye Clinic Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465400
- Sponsor's protocol ID
- 086-Mom-2006-004
- Status last verified
- Dec 2008
- First submitted
- 24 Apr 2007
- Last updated
- 9 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Mayne ST. Antioxidant nutrients and chronic disease: use of biomarkers of exposure and oxidative stress status in epidemiologic research. J Nutr. 2003 Mar;133 Suppl 3:933S-940S. doi: 10.1093/jn/133.3.933S.
PubMed 12612179
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Oxidative Stress in Patients With Age-Related Macular Degeneration Prior to and After Photodynamic Therapy: a Comet Assay Analysis
- ClinicalTrials.gov ID
- NCT00465400
- Acronym / sponsor ID
- 086-Mom-2006-004
- Conditions
- Macular Degeneration
- Keywords
- exudative age-related macular degeneration (AMD), non-exudative age-related macular degeneration (AMD), oxidative stress, photodynamic therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 25 Apr 2007 (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.
First, to quantify, by means of comet assay analysis, systemic oxidative stress in patients with non-exudative and exudative age-related macular degeneration (AMD) and compare results to healthy controls.
Second, to quantify systemic oxidative stress in patients with exudative AMD prior to and after photodynamic (PDT) therapy.
Detailed description
Oxidative stress is the major factor that plays a role in the pathogenesis of age-related macular degeneration (AMD), which is a leading cause of blind registration in the developed world. The term oxidative stress refers to reversible damage to molecules, such as for example DNA, by reactive forms of oxygen (eg. free oxygen radicals). This damage is repaired is normally repaired in our body.
AMD is classified in two forms: the dry (non-exudative) and wet (exudative) form. The exudative form of AMD occurs when new blood vessels form to improve the blood supply to retinal tissue. However, the new blood vessels are very delicate and break easily, causing bleeding and serious vision loss. The standardized method used to treat exudative AMD is photodynamic therapy (PDT). This treatment is based upon the infusion of a drug that can be activated by light and produces free radicals that destroy these newly formed vessels. In other words, these new vessels are destroyed by an iatrogenic source of oxidative stress. This means that the factor that originally caused the disease AMD, namely oxidative stress, is finally used as a form of treatment- to destroy these newly formed blood vessels.
In the present study we would like to quantify in a first step the level of systemic oxidative stress in patients with non-exudative and exudative AMD and compare to healthy controls. In a second step we would like to test whether the treatment (PDT) for patients with exudative AMD additionally increases systemic oxidative stress. Oxidative stress is quantified in our laboratory by means of single cell gel electrophoresis or comet assay.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with macular degeneration
Key inclusion criteria (17 listed)
- Patients between the ages of 50 and 85 yr inclusive.
- Study eye must have a diagnosis of nonexudative "dry" AMD with ≥10 large soft, semisoft, and/or confluent drusen within 3,000 nm of the foveal center.
- Study eye must have a best corrected visual acuity using the ETDRS chart between 0.1 patem and 0.8 patem inclusive.
- Geographic atrophy is allowed as long as it is less than 3 disc diameters within 3,000 nm of the foveal center.
- Study eye must not have conditions that limit the view of the fundus.
Key exclusion criteria (4 listed)
- History of other ocular or systemic disease
- History of chronic or current systemic or topical medication, or of significant drug or alcohol abuse(significant is defined as that which may influence results of the study
- History of ocular trauma or intraocular surgery within the past 6 months
- History of infection or inflammation within the past 3 months
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 9 Dec 2008.
- Background: PubMed 12612179Mayne ST. Antioxidant nutrients and chronic disease: use of biomarkers of exposure and oxidative stress status in epidemiologic research. J Nutr. 2003 Mar;133 Suppl 3:933S-940S. doi: 10.1093/jn/133.3.933S.
Related trials for Macular Degeneration
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
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 Eye Clinic Basel
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 Macular Degeneration, 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 17 inclusion and 4 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 9 Dec 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?
On the ClinicalTrials.gov record for NCT00465400, which also lists 1 linked publication.
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 9 Dec 2008.