Study Evaluating Genotypes Using Lucentis

University of Utah65 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Age-Related Maculopathy

Interventions

LucentisDRUG

0.05 mg intravitreal injection

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (3)

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

Outcomes

Primary Outcomes

To determine the VEGF and HTRA1 genotypes associated with improvement in visual acuity

Time frame: 4 months

Secondary Outcomes

Determine VEGF and HTRA1 genotypes associated with change or no change in visual acuity

Time frame: 12 months

Data from ClinicalTrials.gov

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