Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465400
Status:
COMPLETED
Last Update Posted:
2008-12-09
First Post:
2007-04-24
Brief Title:
Oxidative Stress in Patients With Age-Related Macular Degeneration
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Quantification of Oxidative Stress in Patients With Age-Related Macular Degeneration Prior to and After Photodynamic Therapy a Comet Assay Analysis
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Second to quantify systemic oxidative stress in patients with exudative AMD prior to and after photodynamic PDT therapy
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None