Study Evaluating Genotypes Using Lucentis

Age-Related Maculopathy Clinical Trial

— SEAGUL  

Official title:

VEGF and HTRA1 DNA Polymorphisms in Neovascular AMD Pathogenesis and Response to Lucentis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00474695
• Other study ID #: 21441
• Secondary ID: SEAGUL
• Status: Terminated
• Phase: N/A
• First received: May 15, 2007
• Last updated: February 10, 2015
• Start date: May 2007
• Est. completion date: December 2009

Study information

• Verified date: February 2015
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Age-Related Maculopathy

Intervention

Drug:
• Lucentis
0.05 mg intravitreal injection

Locations

Country	Name	City	State
United States	Porter Adventist Hospital	Denver	Colorado
United States	University of Utah, Moran Eye Center	Salt Lake City	Utah
United States	California Retina Consultants	Santa Barbara	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the VEGF and HTRA1 genotypes associated with improvement in visual acuity		4 months	No
Secondary	Determine VEGF and HTRA1 genotypes associated with change or no change in visual acuity		12 months	No