Status:
COMPLETED
Oxidative Stress in Patients With Age-Related Macular Degeneration
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Macular Degeneration
Eligibility:
All Genders
50-85 years
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 contr...
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 ox...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00465400
Start Date
November 1 2006
End Date
December 1 2007
Last Update
December 9 2008
Active Locations (1)
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1
University Eye Clinic Basel
Basel, Canton of Basel-City, Switzerland, 4031