Oxidative Stress in Patients With Age-Related Macular Degeneration

NCT00465400 | Completed

• 1 other identifier: 086-Mom-2006-004
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Degeneration

Keywords

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

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with macular degeneration

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Eye Clinic Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 12612179 BACKGROUND

Biospecimen

Retention: NONE RETAINED

plasma

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Selim Orgül, MD

  University Eye Clinic Basel

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 24, 2007
• First Posted: April 25, 2007
• Study Start: November 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: December 9, 2008

Record last verified: 2008-12

Locations

CH (1)