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CompletedNCT00465400Updated Dec 9, 2008

Oxidative Stress in Patients With Age-Related Macular Degeneration

An observational study in Macular Degeneration, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-12-09.

Sponsored by University Hospital, Basel, Switzerland · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
12
Ages
50 Years to 85 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Macular Degeneration

Keywords

  • exudative age-related macular degeneration (AMD)
  • non-exudative age-related macular degeneration (AMD)
  • oxidative stress
  • photodynamic therapy
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 12 is below the median of 106 across 421 observational studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

patients with macular degeneration

Inclusion criteria

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.

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
12 participants (actual)
Biospecimen retention
None retained
06

Study locations

1 site
  • University Eye Clinic Basel
    Basel, BS 4031, Switzerland
07

References and documents

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 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00465400
Lead sponsor
University Hospital, Basel, Switzerland
First posted
Apr 25, 2007
Start date
Nov 2006
Primary completion
Dec 2007
Completion
Dec 2007
Last update
Dec 9, 2008

Study contacts

Selim Orgül, MD
study director · University Eye Clinic Basel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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