Study Evaluating Genotypes Using Lucentis

NCT ID: NCT00474695

Last Updated: 2015-02-11

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2009-12-31

Brief 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

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.

Conditions

Age-Related Maculopathy

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

1

Active approved treatment

Lucentis

Intervention Type: DRUG

0.05 mg intravitreal injection

Interventions

Lucentis

0.05 mg intravitreal injection

Intervention Type: DRUG

Other Intervention Names

ranibizumab

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Paul S. Bernstein

Professor, Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Bernstein, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

California Retina Consultants

Santa Barbara, California, United States

Porter Adventist Hospital

Denver, Colorado, United States

University of Utah, Moran Eye Center

Salt Lake City, Utah, United States

Countries

United States

References

Zhao L, Grob S, Avery R, Kimura A, Pieramici D, Lee J, Rabena M, Ortiz S, Quach J, Cao G, Luo H, Zhang M, Pei M, Song Y, Tornambe P, Goldbaum M, Ferreyra H, Kozak I, Zhang K. Common variant in VEGFA and response to anti-VEGF therapy for neovascular age-related macular degeneration. Curr Mol Med. 2013 Jul;13(6):929-34. doi: 10.2174/15665240113139990048.

Reference Type: DERIVED

PMID: 23745581 (View on PubMed)

Other Identifiers

SEAGUL

Identifier Type: -

Identifier Source: secondary_id

21441

Identifier Type: -

Identifier Source: org_study_id