Study Evaluating Genotypes Using Lucentis
- Registration Number
- NCT00474695
- Lead Sponsor
- University of Utah
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 65
- Treatment naive AMD patients;
- At least 50 years of age;
- Visual acuity between 20/40 and 20/320
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Lucentis Active approved treatment
- Primary Outcome Measures
Name Time Method To determine the VEGF and HTRA1 genotypes associated with improvement in visual acuity 4 months
- Secondary Outcome Measures
Name Time Method Determine VEGF and HTRA1 genotypes associated with change or no change in visual acuity 12 months
Trial Locations
- 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