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Completed

NCT Number: NCT00469352

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.

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Key information

Conditions

Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Casey Eye Institute, Oregon Health and Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug

Ranibizumab as needed

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
May 4, 2007
Registry last updated
Jul 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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