A Study of Genetic and Environmental Factors and Their Effect on Response to Treatment With Lucentis (Ranibizumab) for Wet AMD
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effect of Genotype and Environmental Risk Factors on Treatment Response to Intravitreal Lucentis (Ranibizumab) for Neovascular AMD|
- The primary outcome measure is clinical treatment response to intravitreal Lucentis, defined as: 'Clinical stabilization' : stabilization of visual acuity. 'Clinical improvement'; 'Clinical progression' [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Establish the association between environmental risk factors and treatment response to intravitreal Lucentis when controlling for genotype [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Association between central macular thickness as measured by ocular coherence tomography (OCT) in response to Lucentis treatment and genotype/environmental risk exposure. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Median number of intravitreal ranibizumab (Lucentis) injections required per patient [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469352
|United States, Oregon|
|Casey Eye Institute, Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Peter J Francis, MD PhD||Casey Eye Institute, Oregon Health and Science University|