Study EvAluating Genotypes While Using Lucentis 2 (SEAGUL2)
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
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||VEGF and HTRA1 DNA Polymorphisms in Neovascular AMD Pathogenesis and Response to Lucentis|
- To determine the genotype at VEGF and HTRA1 SNPs of patients gaining ≥ 0 letters of visual acuity in response to ranibizumab treatment over a 4 month period. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- To determine the genotype at VEGF and HTRA1 SNPs of patients who lose visual acuity (gain <0 letters) at 4, 6 and 12 months after initial treatment. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- To determine whether change in retinal thickness is correlated with genotype [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- To determine the mean number of injections per year patients in the study require. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2008|
|Study Completion Date:||January 2013|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Consented, enrolled subjects will receive multiple open-label intravitreally administered 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months.
Intravitreal injections of 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months.
Other Name: Lucentis
Age-related macular degeneration (AMD) is a progressive disease that causes irreversible visual impairment and blindness in nearly 50 million people globally. Although geographic atrophy and neovascularization represent the advanced forms of AMD, neovascular AMD is the more aggressive form and accounts for almost 90% of blindness from this disease. It is characterized by choroidal neovascularization (CNV) which is the development of abnormal blood vessels underneath the retina. Randomized clinical trials (MARINA, ANCHOR) have conclusively demonstrated that continued intravitreal therapy with Lucentis (ranibizumab) in patients with subfoveal CNV from AMD leads to stabilization of vision in over 90% of patients and improvement in vision in at least a third of the patients and has led to the approval of Lucentis for the treatment of neovascular AMD (see investigator brochure). This study could provide insight as to the reasons that some patients do not experience vision stabilization with Lucentis, and could possibly help physicians to determine which patients are the best candidates for receiving Lucentis.
This is an open-label study of 100 treatment-naïve (study eye only) AMD patients treated on-label with intravitreally administered Lucentis. Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months. Their blood will be genotyped and sequenced for various SNPs on VEGF and HTRA1.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464723
|United States, California|
|Shiley Eye Center, University of California, San Diego|
|San Diego, California, United States, 92093|
|Principal Investigator:||Kang Zhang, MD, PhD||UCSD, Shiley Eye Center|