Viewing Study NCT01464723



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Last Modification Date: 2024-10-26 @ 10:43 AM
Study NCT ID: NCT01464723
Status: COMPLETED
Last Update Posted: 2019-08-14
First Post: 2011-10-31

Brief Title: Study EvAluating Genotypes While Using Lucentis 2
Sponsor: University of California San Diego
Organization: University of California San Diego

Study Overview

Official Title: VEGF and HTRA1 DNA Polymorphisms in Neovascular AMD Pathogenesis and Response to Lucentis
Status: COMPLETED
Status Verified Date: 2019-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SEAGUL2
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: 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 05 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None