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

NCT00469352 | Completed Phase 3

• 1 other identifier: IRB00003335
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Degeneration

Keywords

Pharmacogenetics; Genetics; Treatment response; AMD; Wet AMD; Age-related macular degeneration

Outcome Measures

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'

  12 months

Secondary Outcomes (3)

• Establish the association between environmental risk factors and treatment response to intravitreal Lucentis when controlling for genotype

  12 months

• Association between central macular thickness as measured by ocular coherence tomography (OCT) in response to Lucentis treatment and genotype/environmental risk exposure.

  12 months

• Median number of intravitreal ranibizumab (Lucentis) injections required per patient

  12 months

Interventions

Ranibizumab DRUG

Ranibizumab as needed

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Casey Eye Institute, Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 22253485 DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Peter J Francis, MD PhD

  Casey Eye Institute, Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 2, 2007
• First Posted: May 4, 2007
• Study Start: May 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: July 22, 2011

Record last verified: 2011-07

Locations

US (1)