Study Evaluating Genotypes Using Lucentis (SEAGUL)

Utah System of Higher Education (USHE)

Status: Terminated

Conditions: Age-Related Maculopathy

Treatments: Drug: Lucentis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00474695

21441

SEAGUL

Details and patient eligibility

About

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

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

65 participants in 1 patient group

1

Description:

Active approved treatment

Treatment:

Drug: Lucentis