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

Condition(s) targeted: Macular Degeneration

Intervention: Ranibizumab (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Oregon Health and Science University

Official(s) and/or principal investigator(s):
Peter J Francis, MD PhD, Principal Investigator, Affiliation: Casey Eye Institute, Oregon Health and Science University

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.

Official title: The Effect of Genotype and Environmental Risk Factors on Treatment Response to Intravitreal Lucentis (Ranibizumab) for Neovascular AMD

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Primary outcome: The primary outcome measure is clinical treatment response to intravitreal Lucentis, defined as: 'Clinical stabilization' : stabilization of visual acuity. 'Clinical improvement'; 'Clinical progression'

Secondary outcome:

Establish the association between environmental risk factors and treatment response to intravitreal Lucentis when controlling for genotype

Association between central macular thickness as measured by ocular coherence tomography (OCT) in response to Lucentis treatment and genotype/environmental risk exposure.

Median number of intravitreal ranibizumab (Lucentis) injections required per patient

Median number of intravitreal ranibizumab (Lucentis) injections required per patient

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 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.

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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

Casey Eye Institute, Oregon Health and Science University, Portland, Oregon 97239, United States; Recruiting
Susan Nolte, Phone: 503-494-3616

Starting date: May 2007
Ending date: May 2009
Last updated: November 21, 2008