A Study of Genetic and Environmental Factors and Their Effect on Response to Treatment With Lucentis (Ranibizumab) for Wet AMD

Completed · Phase 3

Conditions studied: Macular Degeneration

In brief

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 within specific genes means that a patient is likely to get better vision from treatment than another patient with different genes.

Key facts

Study ID

NCT00469352

Run by

Oregon Health and Science University

People needed

150

Starts

2007-05-01

Expected to finish

2010-04-01

Last updated by the study team

2011-07-22

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Casey Eye Institute, Oregon Health and Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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