Study EvAluating Genotypes While Using Lucentis 2 (SEAGUL2)
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|ClinicalTrials.gov Identifier: NCT01464723|
Recruitment Status : Completed
First Posted : November 3, 2011
Last Update Posted : January 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Age-Related Macular Degeneration||Drug: Ranibizumab||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||VEGF and HTRA1 DNA Polymorphisms in Neovascular AMD Pathogenesis and Response to Lucentis|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||January 2013|
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
- 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 ]
- 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 ]
- To determine whether change in retinal thickness is correlated with genotype [ Time Frame: 5 years ]
- To determine the mean number of injections per year patients in the study require. [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|