Study Stopped
IND holder relocated from the University of Utah
Study Evaluating Genotypes Using Lucentis
SEAGUL
VEGF and HTRA1 DNA Polymorphisms in Neovascular AMD Pathogenesis and Response to Lucentis
2 other identifiers
observational
65
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2007
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 15, 2007
CompletedFirst Posted
Study publicly available on registry
May 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFebruary 11, 2015
February 1, 2015
2.1 years
May 15, 2007
February 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the VEGF and HTRA1 genotypes associated with improvement in visual acuity
4 months
Secondary Outcomes (1)
Determine VEGF and HTRA1 genotypes associated with change or no change in visual acuity
12 months
Study Arms (1)
1
Active approved treatment
Interventions
Eligibility Criteria
Moran Eye Center Clinic
You may qualify if:
- Treatment naive AMD patients;
- At least 50 years of age;
- Visual acuity between 20/40 and 20/320
You may not qualify if:
- Pregnancy;
- Prior enrollment in a ranibizumab clinical trial;
- Previous therapy in either eye for AMD;
- Concurrent eye disease that could compromise visual acuity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- Genentech, Inc.collaborator
Study Sites (3)
California Retina Consultants
Santa Barbara, California, 93103, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
University of Utah, Moran Eye Center
Salt Lake City, Utah, 84132, United States
Related Publications (1)
Zhao L, Grob S, Avery R, Kimura A, Pieramici D, Lee J, Rabena M, Ortiz S, Quach J, Cao G, Luo H, Zhang M, Pei M, Song Y, Tornambe P, Goldbaum M, Ferreyra H, Kozak I, Zhang K. Common variant in VEGFA and response to anti-VEGF therapy for neovascular age-related macular degeneration. Curr Mol Med. 2013 Jul;13(6):929-34. doi: 10.2174/15665240113139990048.
PMID: 23745581DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Bernstein, MD, PhD
University of Utah
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Ophthalmology
Study Record Dates
First Submitted
May 15, 2007
First Posted
May 17, 2007
Study Start
May 1, 2007
Primary Completion
June 1, 2009
Study Completion
December 1, 2009
Last Updated
February 11, 2015
Record last verified: 2015-02