Age-Related Maculopathy
Conditions
Keywords
Exudative age-related macular degeneration
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.
Interventions
DRUGLucentis
0.05 mg intravitreal injection
Sponsors
Genentech, Inc.
University of Utah
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the VEGF and HTRA1 genotypes associated with improvement in visual acuity | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Determine VEGF and HTRA1 genotypes associated with change or no change in visual acuity | 12 months |
Countries
United States
Outcome results
None listed