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

NCT ID: NCT00469352

Last Updated: 2011-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2010-04-30

Brief 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.

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.

Conditions

Macular Degeneration

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Ranibizumab

Ranibizumab as needed

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Oregon Health & Science University

Principal Investigators

Peter J Francis, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Casey Eye Institute, Oregon Health and Science University

Locations

Casey Eye Institute, Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

References

Francis PJ. The influence of genetics on response to treatment with ranibizumab (Lucentis) for age-related macular degeneration: the Lucentis Genotype Study (an American Ophthalmological Society thesis). Trans Am Ophthalmol Soc. 2011 Dec;109:115-56.

Reference Type: DERIVED

PMID: 22253485 (View on PubMed)

Other Identifiers

IRB00003335

Identifier Type: -

Identifier Source: org_study_id