Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-29 @ 7:25 PM
Study NCT ID:
NCT00474695
Status:
TERMINATED
Last Update Posted:
2015-02-11
First Post:
2007-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating Genotypes Using Lucentis
Sponsor:
University of Utah
Organization:
Study Overview
Official Title:
VEGF and HTRA1 DNA Polymorphisms in Neovascular AMD Pathogenesis and Response to Lucentis
Status:
TERMINATED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
IND holder relocated from the University of Utah
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEAGUL
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.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| SEAGUL | None | None | View |