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

This study has been completed.
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00469352
First received: May 2, 2007
Last updated: July 20, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention Phase
Macular Degeneration
 Drug: Ranibizumab
 Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: May 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ranibizumab
    Ranibizumab as needed
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469352

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

No publications provided by Oregon Health and Science University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Peter Francis, MD, PhD, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00469352     History of Changes
Other Study ID Numbers: IRB00003335
Study First Received: May 2, 2007
Last Updated: July 20, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013