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

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring Pharmacogenetics, Genetics, Treatment response, AMD, Wet AMD, Age-related macular degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Casey Eye Institute, Oregon Health and Science University

Outcomes

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'

Secondary Outcome Measures

Establish the association between environmental risk factors and treatment response to intravitreal Lucentis when controlling for genotype
Association between central macular thickness as measured by ocular coherence tomography (OCT) in response to Lucentis treatment and genotype/environmental risk exposure.
Median number of intravitreal ranibizumab (Lucentis) injections required per patient

Full Information

First Posted
May 2, 2007
Last Updated
July 20, 2011
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT00469352
Brief Title
A Study of Genetic and Environmental Factors and Their Effect on Response to Treatment With Lucentis (Ranibizumab) for Wet AMD
Official Title
The Effect of Genotype and Environmental Risk Factors on Treatment Response to Intravitreal Lucentis (Ranibizumab) for Neovascular AMD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
Pharmacogenetics, Genetics, Treatment response, AMD, Wet AMD, Age-related macular degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Intervention Description
Ranibizumab as needed
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Establish the association between environmental risk factors and treatment response to intravitreal Lucentis when controlling for genotype
Time Frame
12 months
Title
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
Title
Median number of intravitreal ranibizumab (Lucentis) injections required per patient
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J Francis, MD PhD
Organizational Affiliation
Casey Eye Institute, Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Casey Eye Institute, Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22253485
Citation
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.
Results Reference
derived

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

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