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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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