Study Evaluating Genotypes Using Lucentis - Full Text View

Sponsors and Collaborators:	University of Utah Genentech
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00474695

Purpose

The purpose of the study is to investigate whether the efficacy of Lucentis treatment for exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA polymorphisms

Condition	Intervention	Phase
Age-Related Maculopathy	Drug: Lucentis	Phase IV

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Ranibizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	VEGF and HTRA1 DNA Polymorphisms in Neovascular AMD Pathogenesis and Response to Lucentis

Further study details as provided by University of Utah:

Primary Outcome Measures:

To determine the VEGF and HTRA1 genotypes associated with improvement in visual acuity [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine VEGF and HTRA1 genotypes associated with change or no change in visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	65
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Active approved treatment	Drug: Lucentis 0.05 mg intravitreal injection

Detailed Description:

Treatment naive exudative AMD patients will receive Lucentis treatment as standard of care, and followed monthly for 12 months. Standard ophthalmologic exams will be performed, along with ETDRS visual acuity and optical coherence tomography (OCT). A blood sample will be obtained for DNA analysis. The primary outcome measure is change in visual acuity at 4 months after initial Lucentis treatment. Secondary outcomes are change in visual acuity and retinal thickness at 12 months.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Treatment naive AMD patients;
At least 50 years of age;
Visual acuity between 20/40 and 20/320

Exclusion Criteria:

Pregnancy;
Prior enrollment in a ranibizumab clinical trial;
Previous therapy in either eye for AMD;
Concurrent eye disease that could compromise visual acuity

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474695

Locations

United States, California
California Retina Consultants
Santa Barbara, California, United States, 93103
United States, Colorado
Porter Adventist Hospital
Denver, Colorado, United States, 80210
United States, Utah
University of Utah, Moran Eye Center
Salt Lake City, Utah, United States, 84132

Sponsors and Collaborators

University of Utah

Genentech

Investigators

Principal Investigator:

Paul Bernstein, MD, PhD

University of Utah

More Information

Responsible Party:	University of Utah ( Dr. Paul Bernstein )
Study ID Numbers:	21441, SEAGUL
Study First Received:	May 15, 2007
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00474695
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Utah:

Exudative age-related macular degeneration

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on January 16, 2009