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

Oregon Health & Science University (OHSU)

Status and phase

Completed

Phase 3

Conditions

Macular Degeneration

Treatments

Drug: Ranibizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT00469352

IRB00003335

Details and patient eligibility

About

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.

Full 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 choroidal neovascularization, both of which result in significant loss of vision. Development of intravitreal anti-VEGF agents such as ranibizumab has significantly improved outcomes for the neovascular for of the disease. However, it is not possible to predict which individuals will respond to the treatment.

The objective of this study is to establish the association between genetic factors and treatment response to intravitreal Lucentis. This will be accomplished by SNP-genotyping participants for AMD-susceptibility and candidate angiogenesis-pathway genes, collecting environmental risk factor variables and evaluating clinical outcomes. The aim of this pharmacogenetics study will be to identify patients at the outset of their treatment that require more intensive therapy.

Enrollment

150 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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