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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00469352
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : July 22, 2011
Information provided by:
Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: Ranibizumab Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Intervention Details:
  • Drug: Ranibizumab
    Ranibizumab as needed

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Establish the association between environmental risk factors and treatment response to intravitreal Lucentis when controlling for genotype [ Time Frame: 12 months ]
  2. 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 ]
  3. Median number of intravitreal ranibizumab (Lucentis) injections required per patient [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00469352

United States, Oregon
Casey Eye Institute, Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Principal Investigator: Peter J Francis, MD PhD Casey Eye Institute, Oregon Health and Science University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Peter Francis, MD, PhD, Oregon Health & Science University Identifier: NCT00469352     History of Changes
Other Study ID Numbers: IRB00003335
First Posted: May 4, 2007    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: July 2011

Keywords provided by Oregon Health and Science University:
Treatment response
Age-related macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents