Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (AMD)
An Open-label, Long-term, Safety and Tolerability Extension Study of Intravitreal VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration
1 other identifier
interventional
323
2 countries
124
Brief Summary
The primary objective is to assess long-term safety and tolerability of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2009
Typical duration for phase_3
124 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2009
CompletedFirst Posted
Study publicly available on registry
August 25, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
March 23, 2015
CompletedMarch 23, 2015
March 1, 2015
3.7 years
August 20, 2009
August 28, 2014
March 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD
The primary endpoint in the study is the safety and tolerability of Intravitreal Aflibercept Injection in patients with neovascular AMD (Age-related Macular Degeneration) from day 1 through the end of treatment visit (week 180) based on the number of participants who experienced any treatment-emergent adverse event (TEAE). Treatment-emergent adverse events were categorized according to Ocular TEAEs in the study eye, Ocular TEAEs in the fellow eye, and Non-Ocular TEAEs
Baseline (day 1) through end of treatment (Week 180)
Secondary Outcomes (1)
Change in BCVA Letter Score (mLOCF)
Baseline through Week 116
Other Outcomes (2)
Summary of Treatment Duration (Weeks)
Baseline through end of treatment (Week 180)
Summary of Study Duration (Weeks)
Baseline through end of treatment (Week 180)
Study Arms (1)
Open-label Intravitreal Aflibercept Injection
EXPERIMENTALOpen-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
Interventions
Eligibility Criteria
You may qualify if:
- Participation in Study VGFT-OD-0605 through week 96.
- In the opinion of the investigator, the study eye has neovascular AMD and may continue to require treatment.
You may not qualify if:
- Presence of any condition that would jeopardize the patient's participation in this study.
- Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regeneron Pharmaceuticalslead
- Bayercollaborator
Study Sites (124)
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Birmingham (2 Locations), Alabama, United States
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Phoenix (2 Locations), Arizona, United States
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Tucson (2 Locations), Arizona, United States
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Arcadia, California, United States
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Beverly Hills, California, United States
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Campbell, California, United States
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Fresno, California, United States
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Fullerton, California, United States
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La Jolla, California, United States
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Loma Linda, California, United States
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Mountain View, California, United States
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Oakland, California, United States
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Orange, California, United States
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Palm Desert, California, United States
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Sacramento, California, United States
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San Mateo, California, United States
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Santa Ana, California, United States
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Torrance, California, United States
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Westlake Village, California, United States
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Yorba Linda, California, United States
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Colorado Springs, Colorado, United States
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Denver (2 Locations), Colorado, United States
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Bridgeport, Connecticut, United States
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New Haven, Connecticut, United States
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New London, Connecticut, United States
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Altamonte Springs, Florida, United States
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Boynton Beach, Florida, United States
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Fort Myers (2 Locations), Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Orlando (2 Locations), Florida, United States
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Oscala, Florida, United States
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Palm Beach Gardens, Florida, United States
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Pensacola, Florida, United States
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Stuart, Florida, United States
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Tampa, Florida, United States
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Winter Haven, Florida, United States
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Augusta, Georgia, United States
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‘Aiea, Hawaii, United States
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Glenview, Illinois, United States
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Fort Wayne, Indiana, United States
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Indianapolis, Indiana, United States
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New Albany, Indiana, United States
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Iowa City, Iowa, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Bangor, Maine, United States
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Portland, Maine, United States
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Baltimore (3 Locations), Maryland, United States
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Chevy Chase, Maryland, United States
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Hagerstown, Maryland, United States
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Boston (2 Locations), Massachusetts, United States
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Peabody, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Battle Creek, Michigan, United States
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Grand Rapids, Michigan, United States
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Jackson, Michigan, United States
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Southfield, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Florissant, Missouri, United States
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Kansas City, Missouri, United States
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Springfield, Missouri, United States
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St Louis, Missouri, United States
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Missoula, Montana, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Portsmouth, New Hampshire, United States
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Lawrenceville, New Jersey, United States
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Northfield, New Jersey, United States
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Toms River, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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Brooklyn, New York, United States
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Lynbrook, New York, United States
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New York (6 Locations), New York, United States
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Rochester (2 Locations), New York, United States
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Slingerlands, New York, United States
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Syracuse, New York, United States
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Ashland, Oregon, United States
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Portland (3 Locations), Oregon, United States
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Salem, Oregon, United States
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Kingston, Pennsylvania, United States
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Philadelphia (3 Locations), Pennsylvania, United States
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Pittsburgh (2 Locations), Pennsylvania, United States
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West Mifflin, Pennsylvania, United States
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Columbia, South Carolina, United States
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Greenville, South Carolina, United States
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West Columbia, South Carolina, United States
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Rapid City, South Dakota, United States
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Nashville, Tennessee, United States
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Austin (3 Locations), Texas, United States
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Dallas, Texas, United States
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Fort Worth (2 Locations), Texas, United States
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Houston, Texas, United States
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McAllen, Texas, United States
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Odessa, Texas, United States
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San Antonio (2 Locations), Texas, United States
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Tyler, Texas, United States
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Salt Lake City (2 Locations), Utah, United States
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Burlington, Vermont, United States
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Charlottesville, Virginia, United States
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Fairfax, Virginia, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Madison (2 Locations), Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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Ottawa, Ontario, Canada
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Montreal (2 Locations), Quebec, Canada
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Regina, Saskatchewan, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials Administrator
- Organization
- Regeneron
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2009
First Posted
August 25, 2009
Study Start
December 1, 2009
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
March 23, 2015
Results First Posted
March 23, 2015
Record last verified: 2015-03