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

Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00469352
• Other study ID #: IRB00003335
• Status: Completed
• Phase: Phase 3
• First received: May 2, 2007
• Last updated: July 20, 2011
• Start date: May 2007
• Est. completion date: April 2010

Study information

• Verified date: July 2011
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Drug:
• Ranibizumab
Ranibizumab as needed

Locations

Country	Name	City	State
United States	Casey Eye Institute, Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is clinical treatment response to intravitreal Lucentis, defined as: 'Clinical stabilization' : stabilization of visual acuity. 'Clinical improvement'; 'Clinical progression'		12 months	No
Secondary	Establish the association between environmental risk factors and treatment response to intravitreal Lucentis when controlling for genotype		12 months	No
Secondary	Association between central macular thickness as measured by ocular coherence tomography (OCT) in response to Lucentis treatment and genotype/environmental risk exposure.		12 months	No
Secondary	Median number of intravitreal ranibizumab (Lucentis) injections required per patient		12 months	No