Status:
COMPLETED
A Study of Genetic and Environmental Factors and Their Effect on Response to Treatment With Lucentis (Ranibizumab) for Wet AMD
Lead Sponsor:
Oregon Health and Science University
Conditions:
Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to understand whether genes or certain factors in the environment determine how eyes will respond to Lucentis (ranibizumab) treatment. For example, whether having variants...
Detailed Description
Age-related macular degeneration (AMD) is the leading cause of blindness in the developed world. The advanced stages of the disease are characterized by the development of geographic atrophy or choroi...
Eligibility Criteria
Inclusion
- All AMD-related CNV lesion types will be included.
- Age \>50 years
- The study eye must never have received treatment for neovascular AMD
- Visual acuity in treatment eye must be between 20/30 and 20/320 (ETDRS).
Exclusion
- Age \<50 years;
- Previous therapy in either eye for AMD or other retinal disease which may be used in the treatment of AMD;
- Choroidal neovascularization not from AMD;
- Concomitant non-AMD related maculopathy in study eye;
- Active treatment for neovascular AMD in fellow eye;
- Acuity loss or central field loss from non-AMD cause;
- Pigment epithelial detachment without evidence of CNV;
- Individuals in whom Lucentis is contraindicated;
- Participation in another clinical trial in last three months
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception
- Prior enrollment in the study
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2010
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00469352
Start Date
May 1 2007
End Date
April 1 2010
Last Update
July 22 2011
Active Locations (1)
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1
Casey Eye Institute, Oregon Health and Science University
Portland, Oregon, United States, 97239